StudyFinder
Search Results Within Category "Cardiology/Heart"
35 Study Matches
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Isabella Aspromonte - Isabella.Aspromonte@cchmc.org
ALL
1 year to 85 years old
NA
NCT02397668
Inclusion Criteria:
• Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
• Male or female
• Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent and the pediatric patient (if applicable) provides written assent (if able) prior to procedure
• Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfill all of the expected requirements of this clinical protocol
• Children with congenital disease where the Cor PEDIATRIC Tricuspid ECM Valve would be the physiological right-sided valve
Exclusion Criteria:
• Tricuspid annulus too small (\< 10mm) to accommodate the Cor Tricuspid ECM Valve
• Left ventricular ejection fraction (LVEF) \< 25%
• Mean pulmonary pressure \> 50mm Hg or pulmonary vascular resistance greater than 6 Woods Units
• Emergency cardiac procedure. An example would be a person requiring resuscitation and in cardiogenic shock. An unscheduled or unplanned emergency surgery
• Cardiac transplant patient
• Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock
• Patients with a single ventricle where the Cor Tricuspid ECM Valve would be the systemic AV valve
• Documented primary coagulopathy or uncorrected platelet disorder, including thrombocytopenia (absolute platelet count \<30k). Patient can be enrolled regardless of these parameters if in the opinion of the Investigating Surgeon the coagulopathy can be adequately reversed by transfusions. An example would be the reversal of thrombocytopenia by transfusion of platelets
• Documented evidence of intrinsic hepatic disease (defined as liver enzyme values (aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin) that are \> 5 times the upper limit of reference range within 30 days of enrollment, except in association with acute/reversible decompensation as determined by the Investigator)
• Documented evidence of significant renal dysfunction (serum creatinine \> 4.0mg/dl or GFR\< 30 on the modified Schwartz formula)
• Stroke within 30 days prior to enrollment
• Major or progressive non-cardiac disease (liver failure, renal failure, cancer (CA)) that has a life expectancy of less than one year
• Known cancer (cancer-free \<1 year; does not include non-metastatic basal cell carcinoma or cervical carcinoma) and/or undergoing treatment including chemotherapy and radiotherapy
• Hematological disorders (e.g., aplastic anemia) or patients taking bone marrow suppressant drugs
• Known sensitivity to porcine materials
• Contraindication to anticoagulation/antiplatelet therapy (aspirin (ASA) and/or Plavix)
• Patients who are pregnant (method of assessment Investigator's discretion)
• Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study, without CorMatrix written approval
DEVICE: CorMatrix Cor TRICUSPID ECM Valve
Tricuspid Valve Disease
Office, Home, and Ambulatory Blood Pressure (HBPA)
Marissa Donaldson - marissa.donaldson@cchmc.org
ALL
6 years to 19 years old
NCT05297708
Inclusion Criteria:
• Age 6 years to \<19 years old;
• Elevated blood pressure defined as 15% lower than the 95%ile BP based on clinical practice guidelines(CPG) but less than stage II hypertension based on CPG;
• Tolerate ABPM 24 hours;
• Tolerate HBP; and
• Can have diabetes mellitus, obstructive sleep apnea, and attention deficit hyperactivity disorder managed by medication.
• On stable doses of medications known to affect BP such as:
• Corticosteroids
• Calcineurin inhibitors
• Oral decongestants;
• Clinically stable
Exclusion Criteria:
• On antihypertension medications or treated in the last 6 months;
• Pregnant;
• Structural heart disease such as:
• Obstructive valvular disease
• Coarctation of the aorta
• Cardiomyopathy;
• Other secondary causes such as:
• Renal artery stenosis
• Neurological condition with dysautonomia;
• Recent initiation of medications known to affect BP such as:
• Corticosteroids
• Calcineurin inhibitors
• Oral decongestants;
Elevated Blood Pressure
National Collaborative to Improve Care of Children With Complex Congenital Heart Disease (NPC-QIC)
Mark Timbers - mark.timbers@cchmc.org
ALL
Up to 15 month(s) old
NCT02852031
Inclusion Criteria:
* Fetuses or newborns diagnosed with HLHS or other univentricular condition
* Intended to undergo Norwood procedure
Exclusion Criteria:
* None OTHER: Collaborative Learning Network
Hypoplastic Left Heart Syndrome (HLHS)
Quality of Pediatric Resuscitation in a Multicenter Collaborative (pediRES-Q)
Maya Maya Dewan - Maya.Dewan@cchmc.org
ALL
0 years to 18 years old
NCT02708134
Inclusion Criteria:
* Patient received chest compressions for at least 1 minute
* Patient between gestational age ≥37 weeks and 18 years of age
Exclusion Criteria:
* Patient on veno-arterial extracorporeal membrane oxygenation (ECMO) therapy at beginning of CPR event Cardiac Arrest, Cardiopulmonary Arrest
Chest compressions, Cardiopulmonary Resuscitation, Pediatric
Clinical Course Of Disease In Participants With FA-CM
Jaynee.Bartsch@cchmc.org
ALL
6 years and over
NCT06865482
Inclusion Criteria:
* Male or female, ages ≥6 years at the time of signing the informed consent (and assent, if applicable).
* Diagnosis of FA, based on clinical phenotype and genotype (GAA expansion on both alleles or compound heterozygous), with onset of FA occurring at ≤25 years of age
* Confirmed left ventricular hypertrophy (LVH)
* Left ventricular ejection fraction ≥30%
Exclusion Criteria:
* Presence of other form(s) of CM contributing to heart failure (HF), clinically significant cardiac anatomic abnormality or congenital cardiac malformation, clinically significant coronary artery, uncorrected, hemodynamically significant primary structural valvular disease not due to CM
* Currently receiving intermittent or continuous intravenous (IV) inotrope infusion, presence of a ventricular assist device, or history of prior heart transplantation
* Contraindication to cMRI, participants \<12 years of age who cannot complete the cMRI without sedation will instead undergo ECHOs and are exempt from this criterion.
* Prior organ transplantation
* Initiation of cardiac resynchronization therapy (CRT) within 6 months prior to screening.
* History of prior gene transfer or cell therapy.
* Poorly controlled diabetes (hemoglobin A1c ≥8%)
* Active hematologic or solid organ malignancy Friedreich Ataxia, Cardiomyopathy
Friedreich Ataxia, FA-CM, Cardiomyopathy, FA, Cardiac Disease
Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)
Stephanie Lynch, MPH - stephanie.lynch@carelon.com
ALL
18 years and over
NA
NCT07582861
Both mothers and infants are study participants.
• Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
• Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
• CHD diagnosis received between 16.0 and 30.0 weeks gestation.
• Singleton pregnancy.
• Pregnant mother is planning to continue the pregnancy and pursue surgical or transcatheter intervention for the infant. 5\. Pregnant mother is able to participate and complete study assessments in English or Spanish.
• Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
• Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.
• Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
• Postnatal diagnosis of CHD.
• Fetus with a comorbid condition with a predictable and major impact on neurodevelopment (e.g., Trisomy 21, DiGeorge syndrome).
• Pregnant individual is aged \<18 years.
• Pregnant individual is carrying a surrogate pregnancy.
• Consented mother completes \<70% of survey questions at first (baseline) assessment.
Inclusion Criteria:
• Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
• Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
• CHD diagnosis received between 16.0 and 30.0 weeks gestation.
• Singleton pregnancy.
• Pregnant mother is planning to continue the pregnancy and pursue surgical or transcatheter intervention for the infant. 5\. Pregnant mother is able to participate and complete study assessments in English or Spanish.
Exclusion Criteria:
• Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
• Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.
• Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
• Postnatal diagnosis of CHD.
• Fetus with a comorbid condition with a predictable and major impact on neurodevelopment (e.g., Trisomy 21, DiGeorge syndrome).
• Pregnant individual is aged \<18 years.
• Pregnant individual is carrying a surrogate pregnancy.
• Consented mother completes \<70% of survey questions at first (baseline) assessment.
OTHER: HeartGPS
Congenital Heart Disease (CHD)
HeartGPS, CHD, intervention, Parent mental health, Neurodevelopment
Optimal Ventilation for Cardiac Arrest (OPTI-VENT)
Daniel Loeb - Daniel.Loeb@cchmc.org
ALL
37 weeks to 18 years old
NA
NCT07114510
Inclusion Criteria:
* Invasive airway in place at the start of CPR or airway placed within the first 5 minutes
* Received at least 1 minute of CPR.
Exclusion Criteria:
* Lack of commitment to aggressive ICU therapies (e.g., CPR performed as part of end-of-life care.
* Brain death determination prior to the CPR event.
* Out-of-hospital cardiac arrest was the reason for initial admission to the hospital (known poor outcomes).
* Supported by Veno-Arterial Extra Corporeal Membrane Oxygenation at the start of CPR OTHER: OPTI-VENT Bundle, OTHER: Transition, OTHER: None - control
Cardiac Arrest (CA)
Pediatric
RASopathy Biorepository
Lindsey Aschbacher-Smith - lindsey.aschbacher-smith@cchmc.org
ALL
NCT04395495
Inclusion Criteria:
* Patients with a suspected or known diagnosis of any of the group of disorders known as RASopathies (e.g., Neurofibromatosis, Costello Syndrome, Noonan Syndrome). Diagnosis may be made clinically and/or confirmed through genetic testing.
* Unaffected relatives of patients with a suspected or known diagnosis of any of the group of disorders known as RASopathies.
Exclusion Criteria:
* Individuals who do not have a suspected or definite diagnosis of a RASopathy.
* Individuals who do not have a relative with a suspected or definite diagnosis of a RASopathy.
* Patients who do not have the ability/capacity to undergo the informed consent process OR whose parent/legal guardian is unable to undergo the informed consent process. RAS Mutation, Neurofibromatosis 1, Noonan Syndrome, Noonan Syndrome With Multiple Lentigines, Noonan Neurofibromatosis Syndrome, Cardiofaciocutaneous Syndrome, Costello Syndrome, Legius Syndrome, Smith-Kingsmore Syndrome, MTOR Gene Mutation, GATOR-1 Gene Mutation, SYNGAP1-Related Intellectual Disability, DLG4, MAPK1 Gene Mutation
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Amy Pajk - amy.pajk@cchmc.org
ALL
1 minute to 6 months old
NA
NCT07114718
Inclusion Criteria:
• Parental or legal authorized representative provide consent for study enrollment
• Infants \< 6 months of age
• Diagnosis of congenital heart defect with ductal-dependent pulmonary circulation requiring infusion of prostaglandins
• Requires ductus arteriosus stent diameters of 3.5mm or 4mm and stent lengths between 16mm and 28mm
Exclusion Criteria:
• Active blood stream infection
• Active or history of endocarditis
• Body weight \<2.5kg
• Gestational age \<32 weeks at birth
• Complete heart block
• Total Anomalous Pulmonary Venous Return
• Anatomic variation judged to be inappropriate for ductal stenting per the treating interventionalist
• Presence of an aortopulmonary collateral that is expected to require unifocalization
• Non-confluent pulmonary arteries (i.e. isolated pulmonary artery of ductal origin) or bilateral patent ductus arteriosus (PDA)
• Pulmonary atresia with intact ventricular septum with RV-dependent coronary circulation
• Currently participating in an investigational drug study or another device study that would confound the study results
• Patient who is on extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), or dialysis prior to ductal stenting procedure
• Major co-morbidities which, in the opinion of the investigator, would negatively alter expected 1-year survival (e.g., intracranial hemorrhage, renal failure, etc.)
• Patient who is undergoing another transcatheter procedure (e.g., atrial septostomy, aortic arch intervention, or right ventricular outflow tract intervention) during or within 24 hours prior to the ductus arteriosus stenting procedure
• Patient who, at the time of enrollment, is deemed not to be a candidate for eventual stage II palliation of single ventricle heart disease, complete surgical repair, nor transcatheter treatment with resultant biventricular circulation
• Patient who does not plan to return to the enrolling center or another participating center for stage II palliation, complete surgical repair, or definitive catheterization procedure
• Contraindications to peri-procedural anticoagulation
• Known to be non-responsive to aspirin or other antiplatelet therapies
• Known hypersensitivity or allergy to Nickel
• Known hypersensitivity to contrast media that cannot be adequately pre-medicated
DEVICE: Ductus Arteriosus Stent
Congenital Heart Disease, Congenital Heart Disease (CHD)
Ductus Arteriosus Stent, pediatric stent, Lifeline Stent
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Cierra Farrell - cierra.farrell@cchmc.org
ALL
6 years to 17 years old
PHASE2
NCT07058077
Inclusion Criteria:
Inclusion criteria include, but are not limited to:
* Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results
* Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg/dL
* Is receiving either:
* An optimized daily dose of statin (± nonstatin LLT)
* A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus refusal of statin therapy by the participant or legally acceptable representative
* Is on a stable dose of all background LLTs for at least 30 days prior to screening, with no medication or dose changes planned during participation in Part A or Part B
Exclusion Criteria:
Exclusion criteria include, but are not limited to:
* Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH
* Has a history of nephrotic syndrome
* Has any clinically significant malabsorption condition based on investigator assessment
* Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout DRUG: Enlicitide Decanoate, DRUG: Placebo
Heterozygous Familial Hypercholesterolemia (HeFH)
NO During CPB in Neonates to Reduce Risk of AKI
Jaynee Bartsch - jaynee.bartsch@cchmc.org
ALL
1 day to 31 days old
PHASE3
NCT04216927
Inclusion Criteria:
* All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.
Exclusion Criteria:
• Failure to obtain informed consent from parent/guardian
• Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
• Emergency surgery,
• Episode of cardiac arrest within 1 week before surgery,
• Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
• Use of inhaled NO (iNO) immediately prior to surgery,
• Structural renal abnormalities by ultrasound,
• Preoperative AKI,
• Use of other investigational drugs,
• Weight less than \<2 kg,
• Gestational age \<36 weeks,
• Major extracardiac congenital anomalies,
• Non-English speakers.
DRUG: Nitric Oxide, DRUG: Oxygen
AKI, CHD - Congenital Heart Disease, Surgery
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Sarah Speed - sarah.speed@cchmc.org
ALL
29 days to 17 years old
PHASE2
NCT05714085
Inclusion Criteria:
* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.
* Has biventricular physiology with a morphologic systemic left ventricle.
* Is currently receiving stable medical therapy for HF.
* Has left ventricular ejection fraction (LVEF) \<45% assessed within 3 months before randomization.
* Is of any sex/gender, from \>28 days to \<18 years of age inclusive. Must weigh ≥3 kg to participate.
* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.
* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period
Exclusion Criteria:
* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic.
* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.
* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.
* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.
* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.
* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.
* Has unoperated or residual hemodynamically significant congenital cardiac malformations.
* Has hypertrophic or restrictive cardiomyopathy.
* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.
* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.
* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease
* Has severe pulmonary hypertension.
* Requires continuous home oxygen for significant pulmonary disease and/or has known interstitial lung disease.
* Has severe chronic kidney disease.
* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.
* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.
* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation
* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.
* Has received a COVID-19 vaccination within 1 week before randomization. DRUG: Vericiguat tablet, DRUG: Vericiguat suspension, DRUG: Placebo tablet, DRUG: Placebo suspension
Heart Failure, Left Ventricular Systolic Dysfunction
Safety and Efficacy of FETO in CDH Phase III (CDH FETO)
Foong-Yen Lim - foong.yen.lim@cchmc.org
FEMALE
18 years to 50 years old
PHASE3
NCT07187206
Inclusion Criteria:
* Pregnant women 18 years and older, who are able to consent
* Singleton pregnancy
* Gestational age at enrollment is prior to 296 weeks
* Intrathoracic liver herniation
* Isolated Left CDH with o/e LHR \< 30% at enrollment (180 to 295 weeks) or
* Isolated Right CDH with o/e LHR \< 45% at enrollment (180 to 295 weeks)
* Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks
* Cervical length by transvaginal ultrasound \> 20 mm within 24 hours prior to FETO procedure
* Patient meets psychosocial criteria
* Informed consent understood
Exclusion Criteria
* Patient \< 18 years of age
* Multi-fetal pregnancy
* History of natural rubber latex allergy
* Preterm labor, cervix shortened (\< 20 mm at enrollment or within 24 hours prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa.
* Psychosocial ineligibility, precluding consent:
* Inability to reside within 30 minutes of Cincinnati Children's Hospital Medical Center and inability to comply with the travel for the follow-up requirements of the trial.
* The patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Cincinnati Children's Hospital Medical Center.
* Bilateral CDH, isolated LCDH with o/e LHR ≥ 30%, isolated RCDH with o/e LHR \> 45%, as determined by ultrasound.
* No liver herniation into thoracic cavity
* Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.
* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
* History of incompetent cervix with or without cerclage
* Placental abnormalities (previa, abruption, accreta) known at time of enrollment
* Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
* Maternal HIV, Hepatitis-B, Hepatitis-C positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV status is unknown, the patient must be tested and found to have negative results before enrollment.
* Positive Hepatitis B surface antigen or presence of Hepatitis C in maternal blood uterine anomaly such as Mullerian duct abnormality, large or multiple fibroids that prohibit safe fetoscopic procedure
* There is no safe or technically feasible fetoscopic approach to balloon placement
* Participation in another intervention study that influences maternal and fetal morbidity and mortality, or participation in this trial in a previous pregnancy DEVICE: FETO, Fetal Endoluminal Tracheal Occlusion
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary Hypertension
Modulation of SERCA2a of Intra-Myocytic Calcium Trafficking in Cardiomyopathy Secondary to Duchenne Muscular Dystrophy (MUSIC-DMD)
Jaynee Bartsch - jaynee.bartsch@cchmc.org
MALE
18 years and over
PHASE1
NCT06224660
Inclusion Criteria:
* Diagnosis of DMD with confirmatory genetic testing
* Cardiomyopathy with left ventricular scar in at least 3 of 16 segments
* Left ventricular ejection fraction \< 40%
* Individualized, optimized cardiac medical therapy and glucocorticoid treatment for at least 12 months prior to enrollment
* Willing and able to provide informed consent
Exclusion Criteria:
* Abnormal blood pressure
* Non-DMD-related liver function test elevations
* Cystatin C ≥ 1.2 mg/L
* Thrombocytopenia
* Anemia
* Inadequate pulmonary function GENETIC: SRD-001
DMD-Associated Dilated Cardiomyopathy
Simulation Trial of Telemedical Support for Paramedics (R01)
Bradford McClain - bradford.mcClain@cchmc.org
ALL
21 years and over
NA
NCT06441760
Inclusion Criteria:
* Certified Emergency Medical Technicians (EMTs), Advanced EMTs (AEMTs), and Paramedics (EMT-Ps) who provide direct scene response.
* Board-certified Pediatric Emergency Medicine (PEM) and Emergency Medicine (EM) physicians whose practice includes online medical support for EMS are eligible.
* The control arm will include physicians who provide radio/telephone support in usual care at each site. In the intervention arm, experts will be PEM with/without EMS board-certification as they have relevant pediatric training and experience.
Exclusion Criteria:
* EMS personnel providing interfacility transport and/or pediatric specialty transport
* Resident physicians-in-training
* Non-physician providers OTHER: Video teleconsultation, OTHER: Audio support
Emergencies, Cardiopulmonary Arrest, Acute Respiratory Failure, Status Epilepticus
Prehospital emergency care, Emergency medical services (EMS), Paramedics, Infant simulator mannequins, Telemedical support, Critically ill infants and children, Pediatric emergencies
Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial (MIDAS)
Traci Beiersdorfer - Traci.Beiersdorfer@cchmc.org
ALL
Up to 3 month(s) old
PHASE3
NCT06679855
Inclusion Criteria:
* Gestational age at birth ≤27 weeks (and 6 days) and postnatal age \< 3 months at intervention
* Invasive or non-invasive positive pressure respiratory support (does not include low flow nasal cannula)
* Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention
* Decision by clinical team to proceed with PDA closure via surgical ligation or percutaneous cardiac catheterization based on clinical and echocardiography features of hemodynamic significance.
Exclusion Criteria:
* Any major congenital malformation
* Congenital heart disease (except small (≤1mm) muscular ventricular septal defects, or small/moderate (\<3mm) atrial septal defect)
* Acute renal failure defined by urine output \< 0.5 mL/kg/hour OR rise of serum creatinine by 0.3 mg/dL within 48 hours OR rise of serum creatinine more than 40% above baseline serum creatinine within prior 72 hours.
* Systemic administration of vasodilator/inodilator agents
* Prior history of arrhythmia DRUG: Milrinone infusion, DRUG: Placebo infusion
Post-ligation Cardiac Syndrome
The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients)
Allison Ackermann - allison.ackermann@cchmc.org
ALL
6 years to 17 years old
PHASE2
NCT05763953
Inclusion Criteria:
Patients will be eligible for study participation if they meet all of the following criteria at screening:
• Male or female patients
• Part 1: patients 12 to \<18 years of age
• Part 2: patients 6 to \<12 years of age
• Body mass index (BMI) between the 5th and the 85th percentiles interpreted relative sex and age
• History of PSVT documented by ECG or other monitoring modality (e.g., Holter monitor, event recorder) showing SVT involving the Atrioventricular (AV) node (i.e., Atrioventricular nodal reentry tachycardia (AVNRT) or Atrioventricular reentrant tachycardia (AVRT)). If patient had a prior ablation for PSVT, patient must have documented evidence of PSVT post-ablation
• Signed written informed consent/assent obtained
• Per Investigator's decision, females of childbearing potential (defined as any woman or adolescent who has begun menstruation) must additionally satisfy the following criteria:
• Negative pregnancy test at screening
• Adequate contraception, unless total abstinence is used
• Willing and able to comply with study procedures.
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
• History or presence of any of the following at the screening visit:
• Patients with a history of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, atrial tachycardia) are not eligible
• Permanent junctional reciprocating tachycardia
• Ventricular pre-excitation (e.g., delta wave on ECG, Wolff Parkinson White syndrome)
• Second- or third-degree AV block
• Sick sinus syndrome or clinically significant bradycardia (\<50 bpm or equivalent in this patient population) on the resting ECG
• Ventricular tachycardia
• Long QT syndrome
• Major structural heart disease (e.g., Ebstein's anomaly, corrected congenital heart disease) or symptoms of congestive heart failure (New York Heart Association class II to IV).
• Evidence of impaired liver function (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] \>3 x upper limit of normal for age and gender) at the Screening Visit
• Evidence of End-Stage Renal Disease as determined by an estimated glomerular filtration rate assessed at the Screening Visit of \<15 mL/min/1.73m2, or requiring hemodialysis;
• Treatment with any of the following that cannot or will not be discontinued during study participation:
• Any investigational drug within 60 days prior to study drug administration
• IV beta-adrenergic blocking drugs (e.g., propranolol, esmolol), calcium channel blocking drugs (e.g., verapamil, diltiazem) or amiodarone within 24 hours prior to study drug administration
• Oral amiodarone within 30 days prior to study drug administration
• Class I or III antiarrhythmic agents (e.g., flecainide, propafenone, sotalol) within five half-lives prior to study drug administration
• Any other drug that has a contraindication with verapamil
• Known hypersensitivity to verapamil or to any of the excipients of the study drug
• Any other significant co-morbid condition that may have a negative impact on the patient's participation in the study or likely to result in non-compliance
• History of hyperthyroidism
• Current pregnancy or breastfeeding
DRUG: Etripamil NS
Paroxysmal Supraventricular Tachycardia
PSVT
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction (FIORE)
Elise Pickering - Elise.Pickering@cchmc.org
ALL
6 months to 17 years old
PHASE3
NCT07188805
Inclusion Criteria:
* Participants must be 6 months to \<18 years old at the time when the informed consent/assent is signed.
* Left ventricular systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography.
* Elevated NT-pro BNP levels
* \>500 ng/l for children ≥ 6 months to \< 2 years of age
* \>300 ng/l, for children ≥ 2 years to \<18 years
* Heart failure etiologies including congenital heart defects (CHD) with biventricular physiology and systemic LV; idiopathic cardiomyopathy (CM); familial/inherited and/or genetic CM; history of myocarditis (diagnosis of an acute episode was at least 3 months prior to randomization); neuromuscular disorder (eg, duchenne muscular dystrophy); inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (eg, Kawasaki disease and postoperative heart failure \[HF\]); LV noncompaction.
* Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion and being on a stable regimen for 30 days prior to randomization.
* Study participants must have a body weight ≥ 4.0 kg at Visit 1.
Exclusion Criteria:
* Serum potassium:
* \> 5.0 mmol/L for children ≥ 2 years of age at either screening or randomization visit
* \> 5.3 mmol/L for children ≥ 6 months to \< 2 years of age at either screening or randomization visit (if estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73m², threshold of \> 5.0 mmol/L will be used)
* Severe renal dysfunction with eGFR \< 30 ml/min/1.73m² at screening or randomization visit.
* Systolic blood pressure (SBP) \< 5th percentile for age, sex and height at screening or randomization.
* Sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to randomization.
* Treatment with a mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone) within 30 days of randomization.
* Requirement of any intravenous (IV) vasoactive agents, mechanical ventilation, mechanical circulatory support within 30 days prior to randomization.
* Recent surgical procedure or other intervention to correct or palliate CHD within 3 months prior to randomization or anticipated to undergo cardiac surgery during the 3 months after randomization. DRUG: Finerenone (Kerendia, BAY94-8862), DRUG: Placebo
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction (FIORELLO)
Elise Pickering - elise.pickering@cchmc.org
ALL
Up to 18 years old
PHASE3
NCT07192952
Inclusion Criteria:
* For participants rolling over from randomized controlled trial (RCT): Prior participation in the finerenone Phase 3 study FIORE (21466) and not permanently discontinued from the study intervention prior to the end of treatment (EoT) visit in FIORE.
* For newly enrolled infants \<6 months of age: Left ventricular systolic dysfunction (LVSD) with left ventricular ejection fraction (LVEF) ≤ 50% at screening assessed by echocardiography.
* For newly enrolled infants \<6 months of age: Elevated NT-pro BNP levels (\> 500 mg/L) at screening.
* For newly enrolled infants \<6 months of age: Heart failure (HF) etiologies include congenital heart defects (CHD) with biventricular physiology and systemic LV; idiopathic cardiomyopathy (CM); familial/inherited and/or genetic CM; history of myocarditis (diagnosis of an acute episode at least 3 months prior to treatment assignment); neuromuscular disorder; inborn error of metabolism; mitochondrial disorder; acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional); ischemic (e.g., Kawasaki disease and postoperative HF); LV noncompaction.
* For newly enrolled infants \<6 months of age: Receiving standard of care (SoC) treatment for heart failure according to local guidelines or investigator´s discretion (on a stable regimen for 30 days before baseline).
* Newly enrolled newborns and infants \< 6 months of age must have a body weight of ≥3 kg at Visit 1.
Exclusion Criteria:
* For participants rolling over from randomized controlled trial (RCT): To roll-over to FIORELLO, all participants: Potassium (K+) \>5.5 mmol/L. After unblinding:
* For participants who received finerenone in FIORE: K+ \>5.5 mmol/ L
* For participants who received placebo in FIORE: K+ \>5.0 mmol/L for children ≥2 years of age, and \>5.3 mmol/L for children \<2 years of age (if eGFR is \<60 mL/min/1.73m² for participants \<2 years of age, the serum potassium threshold of \>5.0 mmol/L will be used for exclusion)
* For newly enrolled newborns and infants \< 6 months of age: Potassium ≥ 5.3 mmol/l (if eGFR is \<60 mL/min/1.73m², the serum potassium threshold of \>5.0 mmol/L will be used for exclusion).
* For participants rolling over from RCT: Severe renal dysfunction with estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m² at FIORE EoT or Visit 1.
* For newly enrolled infants \< 6 months of age: Severe renal dysfunction with eGFR \< 30 ml/min/1.73m2 at screening or Visit 1.
* Treatment with a mineralocorticoid receptor antagonist, other than the study intervention, (e.g., spironolactone, eplerenone) within 30 days of Visit 1.
* Requirement of any intravenous (IV) vasoactive agents; mechanical ventilation; mechanical circulatory support; sustained or symptomatic arrhythmias not controlled by drug or device therapy within 30 days prior to study treatment. DRUG: Finerenone (Kerendia, BAY94-8862)
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Amy Pajk - amy.pajk@cchmc.org
ALL
NA
NCT02744677
Inclusion Criteria:
• Weight ≥ 20 kg (44 lbs.)
• Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use
• Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
• The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria:
• Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
• History of or active endocarditis (active treatment with antibiotics) within the past 180 days
• Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
• Inappropriate anatomy for femoral introduction and delivery of the study valve
• Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
• Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
• Interventional/surgical procedures within 30 days prior to the TPVI procedure.
• Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
• History of or current intravenous drug use
• Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
• Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
• Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
• Participating in another investigational drug or device study that has not reached its primary endpoint.
• Female who is lactating or pregnant
DEVICE: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, DEVICE: SAPIEN 3 THV, DEVICE: SAPIEN 3 Ultra RESILIA THV
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
Tetralogy of Fallot, Aortic Valve Defect/Disease Resulting in Ross Procedure, Pulmonary Atresia, Pulmonary Stenosis, Truncus Arteriosus, Transposition of the Great Arteries, Transcatheter pulmonary valve implantation, Transcatheter pulmonary valve replacement, TPV, TPVR, TPVI
Identification of Biomarkers for Patients with Vascular Anomalies
- hvmcresearch@cchmc.org
ALL
Not specified
NCT03001180
Inclusion Criteria:
* Any patient having labs drawn as standard of care will have blood drawn for the study if consented/ assented.
* All patients who are undergoing a surgical procedure or sclerotherapy are currently consented for participation in the tissue bank.
Exclusion Criteria:
* N/A Vascular Anomaly, Generalized Lymphatic Anomaly, Kaposiform Hemangioendothelioma, Kaposiform Lymphangiomatosis, Gorham-Stout Disease, Klippel Trenaunay Syndrome, Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi
Generalized Lymphatic Anomaly, Vascular Anomaly, Kaposiform Hemangioendothelioma, Kaposiform Lymphangiomatosis, Vascular Endothelial Growth Factor, Biomarkers, GLA, KLA, KHE, GSD
Minima Stent System Post- Approval Study (PAS)
Amy Amy Pajk - Amy.Pajk@cchmc.org
ALL
NCT06828770
Inclusion Criteria:
* The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent
* Indicated for treatment with the Minima Stent System per the IFU.
Exclusion Criteria:
* Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation
* History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation
* Aortic or pulmonary artery aneurysm in the location targeted for treatment
* Body weight \< 1.5 kg
* Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent
* Target vessels larger or smaller than the Minima System balloon size ranges
* Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc
* Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure.
* Currently participating in an investigational drug study or another device study
* Major or progressive non-cardiac disease resulting in a life expectancy of less than six months
* Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
* Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately premedicated DEVICE: Minima Stent System
Pulmonary Artery Stenosis, Aortic Coarctation
Vascular Stenosis, Minima, Minima Stent, Minima Stent System, Renata Medical, Renata, infant stent
A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study)
Sarah Price - Sarah.price@cchmc.org
ALL
2 years and over
PHASE2
NCT06789913
Key
• Systemic therapy or antibody within 5 half-lives of the therapy.
• Local therapy including radiation, surgery, or other procedures within 28 days; lesion(s) must have demonstrated progression after the procedure.
Inclusion Criteria:
* The participant must have a clinical diagnosis of PROS or a malformation within the ISSVA classification.
* One or more documented activating PIK3CA mutation(s) that are targeted by selective PI3Kα inhibitors in lesional tissue and/or cell-free DNA from the lesion or blood. Some participants may be eligible without a documented PIK3CA mutation, with the sponsor's approval, as long as no other genetic driver has been documented.
* Lansky (\<16 yo) or Karnofsky (≥16 yo) performance status of ≥50.
* Agree to provide archived lesional fluid and/or tissue or be willing to undergo pretreatment lesional biopsy (if considered safe and medically feasible) to assess PIK3CA status.
Key Exclusion Criteria:
* Known hypersensitivity to RLY-2608.
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
* Clinically significant, uncontrolled cardiovascular disease
* Received disease-directed therapy prior to the first dose of study drug:
• Systemic therapy or antibody within 5 half-lives of the therapy.
• Local therapy including radiation, surgery, or other procedures within 28 days; lesion(s) must have demonstrated progression after the procedure.
DRUG: RLY-2608, DRUG: Placebo
PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations, Vascular Malformations, PIK3CA Mutation, CLOVES Syndrome, Klippel Trenaunay Syndrome, Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP), Vascular Anomalies
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Abigayle Gibson - abigayle.gibson@cchmc.org
ALL
2 days to 17 years old
NA
NCT05376267
Inclusion criteria:
* Age 2 days to \< 18 years with corrected gestational age of at least 38 weeks
* Chest compressions for at least 2 minutes
* Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA)
* Requires continuous mechanical ventilation through endotracheal tube or tracheostomy
* Definitive temperature control device initiated
* Randomization within 6 hours of Return of Spontaneous Circulation (ROSC)
* Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours
Exclusion criteria:
* Glasgow Coma Motor Score (GCMS) = 6
* LAR does not speak English or Spanish
* Duration of Cardiopulmonary Resuscitation (CPR) \> 60 minutes
* Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg/kg/minute) or initiation of Extracorporeal membrane oxygenation (ECMO)
* Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy
* Pre-existing terminal illness, unlikely to survive to one year
* Cardiac arrest associated with brain, thoracic, or abdominal trauma
* Active and refractory severe bleeding prior to randomization
* Extensive burns or skin lesions incompatible with surface cooling
* Planned early withdrawal of life support before 120 hours
* Sickle cell anemia
* Pre-existing cryoglobulinemia
* Non-fatal drowning in ice covered water
* Central nervous system tumor with ongoing chemotherapy
* Previous enrollment in P-ICECAP trial
* Prisoner
* Chronic hypothermia
* New post-cardiac arrest diabetes insipidus
* Pregnancy
DEVICE: Therapeutic Hypothermia
Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced, Hypoxia-Ischemia, Brain
Bayesian Adaptive Clinical Trial, Hypothermia, therapeutic, Coma, Pediatric
Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
Lara Danziger-Isakov, MD - Lara.Danziger-Isakov@cchmc.org
ALL
Up to 18 years old
NCT05550298
Recipient Inclusion Criteria
* Less than 18 years at the time of anticipated transplant
* Participant meets one of the following criteria:
• scheduled to receive allogeneic hematopoietic cell transplant within 14 days of enrollment or
• Scheduled to or received solid organ transplant within 7 days before or after enrollment * Participant is receiving care at the time of enrollment at one of the study participating institutions. * Parent/guardian willing and able to provide informed consent, and if appropriate, child willing and able to provide informed assent. Donor Inclusion Criteria * Donor for HCT recipient enrolled on the VIPER study. * Willing and able to provide informed consent.
• scheduled to receive allogeneic hematopoietic cell transplant within 14 days of enrollment or
• Scheduled to or received solid organ transplant within 7 days before or after enrollment * Participant is receiving care at the time of enrollment at one of the study participating institutions. * Parent/guardian willing and able to provide informed consent, and if appropriate, child willing and able to provide informed assent. Donor Inclusion Criteria * Donor for HCT recipient enrolled on the VIPER study. * Willing and able to provide informed consent.
Exclusion Criteria:
Recipient Exclusion Criteria
None
Donor Exclusion Criteria
* Is not an HCT donor for a participant enrolled on the VIPER study.
* Not available to provide pre-transplant research blood sample. Hematopoietic Cell Transplant, Solid Organ Transplant, Respiratory Viral Infection
MASA Valve Early Feasibility Study (MVEFS)
Joshua Freytag - Joshua.Freytag@cchmc.org
ALL
0 years to 22 years old
NA
NCT05452720
Inclusion Criteria:
• At least one of the following: Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis.
• Age \< 22 years
• Patient is geographically stable and willing to return for 1 year follow-up for the trial.
• Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.
• The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.
Exclusion Criteria:
• Patient is in need of or has presence of a prosthetic heart valve at any other position
• Patient has a need for concomitant surgical procedures (non-cardiac)
• Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
• Patient has an active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
• Patient has an active endocarditis
• Leukopenia, according to local laboratory evaluation of white blood cell count
• Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
• Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria
• Severe chest wall deformity, which would preclude placement of the PV conduit
• Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
• Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
• Patient has chronic inflammatory / autoimmune disease
• Need for emergency cardiac or vascular surgery or intervention
• Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
• Currently participating, or participated within the last 30 days, in an investigational drug or device study
• Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months
• Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance
DEVICE: Surgical Right Ventricular Outflow Tract Reconstruction
Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus, Transposition of Great Vessels, Pulmonary Atresia, Ross Procedure
Right Ventricular Outflow Tract Reconstruction, Pulmonary Valve, MASA Valve, Pulmonary Valve Replacement
Pulmonary Hypertension Association Registry (PHAR)
Jaynee Bartsch - jaynee.bartsch@cchmc.org
ALL
Not specified
NCT04071327
Inclusion Criteria:
* All age groups
* Written informed consent
* Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), or pediatric PH due to developmental lung disease
* Within 6 months of first outpatient visit at a PH Care Center
Exclusion Criteria:
* Diagnosis of WSPH Group 2 pulmonary hypertension
* Diagnosis of WSPH Group 3 pulmonary hypertension, except PH due to developmental lung disease
* Diagnosis of WSPH Group 5 pulmonary hypertension Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Hypertension
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis (HeartGPS)
- heartgps@cchmc.org
ALL
18 years and over
NA
NCT06175104
Inclusion Criteria
• Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
• Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
• Singleton pregnancy.
• Pregnant person is planning to continue with the pregnancy.
• Pregnant person is able to participate and complete study assessments in English. Exclusion Criteria
• Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
• Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
• Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.
• Parent with a moderate to severe intellectual disability.
• Parent age \<18 years.
• Surrogate for pregnancy. Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.
• Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
• Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
• Singleton pregnancy.
• Pregnant person is planning to continue with the pregnancy.
• Pregnant person is able to participate and complete study assessments in English. Exclusion Criteria
• Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
• Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
• Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.
• Parent with a moderate to severe intellectual disability.
• Parent age \<18 years.
• Surrogate for pregnancy. Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.
BEHAVIORAL: HeartGPS
Heart Defects, Congenital, Anxiety in Pregnancy, Depression, Postpartum, Trauma, Psychological, Neurodevelopmental Disorders
Congenital Heart Disease, Prenatal, Mental Health, Neurodevelopment, Neurobehavior, Fetal Cardiology, Psychological Intervention, Mother-Infant Attachment, Mother-Infant Bonding, Medical Traumatic Stress, Neuroimaging, Brain Development, Fetal Neuroimaging, Perinatal Mental Health, Medical Psychology
Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders (HIBR-ACHD)
Olivia Croweak - 0livia.croweak@cchmc.org
ALL
16 years and over
NCT07477197
Inclusion Criteria:
• Any person ≥ 16 years-old suspected of having or diagnosed with congenital heart disease (CHD), other cardiovascular disease (CVD), pulmonary hypertension, connective tissue disease, or genetic syndrome/diagnosis.
• Additionally, a cohort (Control group A) of control subjects will be enrolled, again ≥16 years-old, self-reported non-smokers without a known history of diabetes mellitus, myocardial infarction, stroke, heart failure, or chronic kidney disease. These controls will be either:
• A family member or other person accompanying a patient to a clinical encounter; or,
• A volunteer recruited via an advertisement; or,
• Another person who volunteers to enroll in HIBR-ACHD.
• A cohort (Control group B) of comparison subjects who do not have CHD, but have a diagnosis of heart failure or pulmonary hypertension.
Exclusion Criteria:
* Unable to provide informed consent/assent personally or via a legal guardian.
* Considered unsafe to collect the biospecimen determined by either a clinical provider or an HIBR-ACHD investigator.
* Overnight hospitalization for non-obstetric reason with discharge in the prior 30 days. Adult Congenital Heart Disease, Pulmonary Hypertension, Connective Tissue Disease, Other Cardiovascular Conditions
ACHD, Adult Congenital Heart Disease
Heart Institute BioRepository (HIBR) for Pediatric Heart Disease (HIBR)
Olivia Croweak - olivia.croweak@cchmc.org
ALL
NCT07478354
Inclusion Criteria
* Any fetus, child or adult at risk of or diagnosed with Pediatric Heart Disease (PHD) or Cardiovascular Disease (CVD)
* Any HI patient, including the following types of encounters: Surgery or Cardiac Catheterization or Advanced Imaging encounters, Inpatient, including Cardiology service, consultation patients and Fetal Delivery, and Outpatient, including all HI-associated clinics and consultation services
* Any female carrying a fetus with a suspected cardiac diagnosis
Exclusion Criteria
* Legal guardian unauthorized to consent
* Families who choose Palliative care during pregnancy
Cardiovascular Diseases (CVD)
cardiovascular disease, Pediatric Heart disease