NCT07477197 Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders
| NCT ID | NCT07477197 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Adult Congenital Heart Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2050-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2021-07-01 with a primary completion date of 2050-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A repository of biospecimens and detailed phenotypic information collected longitudinally from adults with congenital heart disease and related conditions, with an aim to facilitate future research on biologic mechanisms of underlying disease, compensation and deterioration; biologic correlates of patient experience and functional status; associations between clinical characteristics and various biomarkers; and predictors of clinical outcomes.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. 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: 1. A family member or other person accompanying a patient to a clinical encounter; or, 2. A volunteer recruited via an advertisement; or, 3. Another person who volunteers to enroll in HIBR-ACHD. 3. 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.
Contact & Investigator
Sasha Opotowsky
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT07477197 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Adult Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07477197 currently recruiting?
Yes, NCT07477197 is actively recruiting participants. Contact the research team at sasha.opotowsky@cchmc.org for enrollment information.
Where is the NCT07477197 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT07477197 clinical trial?
NCT07477197 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Sasha Opotowsky at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 5,000 participants.