Heart Institute Biobank and Registry for Adults with Congenital Heart Disease and Related Conditions
Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders
This project will collect blood, tissue samples, and detailed health information from adults (≥16) with congenital heart disease and related heart or vascular conditions to create a resource researchers can use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT07477197 on ClinicalTrials.gov |
What this trial studies
The program enrolls adults (age ≥16) with congenital heart disease and related disorders, along with two comparison control groups, and collects biospecimens and detailed clinical data on an ongoing basis. Participants provide samples at clinical encounters and complete surveys and patient-reported outcome measures to capture symptoms, lifestyle, and functional status. All specimens and linked phenotypic data are stored longitudinally to support future research on biological mechanisms, biomarkers, and predictors of clinical outcomes. Enrollment is conducted at the Heart Institute with plans for possible expansion to additional cardiology sites after review.
Who should consider this trial
Good fit: Ideal candidates are adults aged 16 or older with diagnosed or suspected congenital heart disease or related cardiovascular, pulmonary hypertension, or connective tissue disorders who can provide informed consent and donate biospecimens and health information.
Not a fit: People unable to give informed consent, those considered unsafe for biospecimen collection, or those expecting direct therapeutic benefit from participation are unlikely to receive direct clinical benefit from enrollment.
Why it matters
Potential benefit: If successful, this biobank could help researchers identify biomarkers and mechanisms that improve diagnosis, risk prediction, and personalized care for adults with congenital heart disease.
How similar studies have performed: Other cardiovascular biobanks and registries have successfully linked biospecimens to clinical outcomes and biomarker discoveries, though longitudinal, adult congenital heart disease-specific resources are less common.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cincinnati, Ohio
- Children's Hospital Medical Center, Cincinnati — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Sasha Opotowsky — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Sasha Opotowsky, MD
- Email: sasha.opotowsky@cchmc.org
- Phone: 513-803-2243
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.