StudyFinder
Search Results Within Category "Cardiology/Heart"
35 Study Matches
BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease
- olivia.cleary@cchmc.org
ALL
18 years and over
NA
NCT07582848
Both mothers and infants are study participants.
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.
• Admission to the ICU (either CICU or NICU) at participating center in 1st week of life and for whom cardiac surgical or transcatheter intervention is anticipated in the first 30 days of life.
• Willing to comply with protocol and provide written informed consent
• 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.
• Infant birthweight \<3rd percentile for gestational age
• Infant gestational age \< 36 weeks
• Infant with known genetic disorder likely to impact breastfeeding, such as trisomy 21 or cleft palate
• Medical condition or congenital anomaly that precludes safe direct breastfeeding for the infant as determined by investigator
• 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.
• Admission to the ICU (either CICU or NICU) at participating center in 1st week of life and for whom cardiac surgical or transcatheter intervention is anticipated in the first 30 days of life.
• Willing to comply with protocol and provide written informed consent
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.
• Infant birthweight \<3rd percentile for gestational age
• Infant gestational age \< 36 weeks
• Infant with known genetic disorder likely to impact breastfeeding, such as trisomy 21 or cleft palate
• Medical condition or congenital anomaly that precludes safe direct breastfeeding for the infant as determined by investigator
OTHER: Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)
Congenital Heart Disease (CHD)
Direct breastfeeding, CHD, Infant neurodevelopment, Maternal Mental Health
A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study (PHN WBC)
Elise Pickering - Elise.Pickering@cchmc.org
ALL
12 years to 17 years old
NA
NCT07525843
Inclusion Criteria:
* Age 12-17 years old
* CHD of moderate or severe complexity (Class II/III, 2018 AHA/ACC ACHD, Table 4)
* English or Spanish language proficiency
* Receives cardiology care at a PHN or PHN auxiliary site
* Parent or guardian and participant willing to comply with protocol and provide written/electronic informed consent and assent
Exclusion Criteria:
* CHD of mild or simple complexity (Class I, 2018 AHA/ACC ACHD, Table 4)
* Prior heart transplant to treat CHD
* Heart disease that is not classified as structural CHD (e.g., connective tissue disease, genetic cardiomyopathy, or acquired heart disease)
* Cognitive or developmental conditions that limit program participation and/or ability to complete self-reported measures as determined by a primary cardiology clinician
* Suicidality, homicidality, or psychosis in the past 12 months as per medical chart review, clinician report, or eligibility screening
* Medically unable to participate (e.g., intubated, unable to respond verbally, active delirium) BEHAVIORAL: Telemedicine-based resiliency-building intervention
Patient-Reported Outcome Measures (PROMs), Pragmatic Trial, Adolescent Congenital Heart Disease, Resiliency-building Intervention, Resilience, Psychological, Telemedicine-Based Education
WE BEAT, Well-Being Education Program, Adolescent CHD, Pragmatic Clinical Trial, Telemedicine
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008) (MOONBEAM)
Jaynee Bartsch - jaynee.bartsch@cchmc.org
ALL
1 year to 17 years old
PHASE2
NCT05587712
Inclusion Criteria
* Documented, historic diagnostic right heart catheterization (RHC) any time before Screening confirming the diagnosis of PAH WHO Group 1 in any of the following subtypes:
* Idiopathic pulmonary arterial hypertension (IPAH)
* Heritable PAH
* Drug/toxin-induced PAH
* PAH associated with connective tissue disease
* PAH-congenital heart disease (CHD) with shunt closure \>6 months before Screening and subsequently confirmed by RHC before Screening
* PAH with coincidental shunt.
* Must be on a stable dose(s) of background PAH therapy (phosphdiesterase-5 (PDE5) inhibitors, endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulators (sGCS), or prostanoids \[including subcutaneous and intravenous\])
* If male, agree to the following during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention:
* Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent or
* Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:
* Uses a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
* If female, must be either not a WOCBP or use a contraceptive method that is highly effective or be abstinent from heterosexual intercourse during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention
* If male, agrees to refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study intervention
* If female, agrees to refrain from donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study intervention
Exclusion Criteria
* History of left-sided heart disease, including valvular disease (eg, moderate or greater mitral or aortic regurgitation or stenosis), left ventricular outflow tract obstruction, and/or left heart failure (eg, restrictive or dilated cardiomyopathy)
* Severe (as based on the opinion of the investigator) congenital or developmental abnormalities of the lung, thorax, and/or diaphragm
* History of Eisenmenger syndrome, Potts shunt, or atrial septostomy
* Unrepaired or residual cardiac shunt
* Diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary hemangiomatosis, or overt signs of capillary and/or venous involvement
* PAH associated with portal hypertension
* Known visceral (lung, liver, or brain) arteriovenous malformation(s)
* History of full or partial pneumonectomy
* Untreated more than mild obstructive sleep apnea
* History of known pericardial constriction
* Family history of sudden cardiac death or long QT syndrome
* Any current or prior history of symptomatic coronary disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months before Screening
* Cerebrovascular accident within 3 months before Screening
* Prior exposure to sotatercept or luspatercept or has had an allergic reaction to any of their excipients
DRUG: Sotatercept
Pulmonary Arterial Hypertension
Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry (PPHNet)
Sarah Speed - sarah.speed@cchmc.org
ALL
1 day to 21 years old
NCT02249923
Inclusion Criteria:
* The subject's age of onset of pulmonary hypertension must be prior to age 18 years
* The person providing consent must be able to read either Spanish or English.
* The subject (and/or parent/legal guardian) must be able to provide informed consent
Exclusion Criteria:
* Diagnosed with pulmonary hypertension after age 18
* Refusal to sign informed consent Pulmonary Vascular Disease, Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease (PVD), Registry, Pediatric
A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma
- cancer@cchmc.org
ALL
7 years and over
NCT05705531
Inclusion Criteria:
* Patient must be \>= 7 years of age at the time of enrollment (age to perform an MRI without sedation).
* History of pathologically confirmed classical Hodgkin Lymphoma (cHL) initially diagnosed when the patient was \>= 2 and \< 22 years of age.
* As part of frontline therapy for cHL, the patient must have received a cumulative doxorubicin equivalent anthracycline dose of ≥ 200 mg/m\^2 as estimated in doxorubicin isotoxic equivalents dose conversion calculation.
* Note: History of COG therapeutic trial participation is not required. Institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) can be used as reference documentation of receipt of anthracycline dose.
* All systemic cancer treatment must have been completed ≥ 2 years prior to study enrollment.
* Not known to have had a primary event (relapse/second malignancy/death).
* Note: Subjects treated at another institution are eligible if they are now being followed at the current COG institution, if the study procedures can be performed and the data accessible by a COG institution where the study is open.
* Patient must have access to cardiac MRI at the enrolling institution and must be able to complete cardiac MRI without sedation.
Exclusion Criteria:
* Medical contraindication to undergoing a non-contrast cardiac MRI.
* Patients with nodular lymphocyte-predominant HL.
* Received cancer therapy in addition to that for primary Hodgkin Disease (e.g., for disease progression or recurrence, or subsequent malignant neoplasm).
* History of CTCAE grade 3 or higher cardiovascular disease or condition known to exist prior to the patient's initial diagnosis of cHL.
* Note: exceptions are made for congenital conditions considered fully resolved by surgery and chronic conditions such as hypertension or hypercholesterolemia that are managed with medical intervention.
* History of an immunodeficiency that existed prior to cHL diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and conditions requiring systemic immunosuppressive agents. PROCEDURE: Archive Sample Retrieval, PROCEDURE: Biospecimen Collection, OTHER: Electronic Health Record Review, PROCEDURE: Magnetic Resonance Imaging, OTHER: Survey Administration
Cardiovascular Disorder, Classic Hodgkin Lymphoma, Clonal Hematopoiesis