Heart Institute Biorepository for children with heart disease
Heart Institute BioRepository (HIBR) for Pediatric Heart Disease
This project collects and stores blood, tissue, and other samples from people with pediatric heart disease so researchers can use them to learn more and develop new tests and treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT07478354 on ClinicalTrials.gov |
What this trial studies
The Heart Institute Biorepository is a prospective and retrospective observational collection that acquires, processes, organizes, and stores biological samples from patients seen at the Heart Institute. Samples include whole blood for DNA, plasma, urine, saliva, cardiovascular tissue, and explanted non-human prosthetics or grafts, and may be collected at surgery, catheterization, clinic visits, delivery, or other clinical encounters. The repository performs limited laboratory processing such as DNA isolation, plasma separation, and B-lymphocyte transformation to create immortalized cell lines and preserve genomic material for future use. Stored specimens are governed for investigator-initiated, translational, clinical, and outcomes research to serve institutional and broader research needs.
Who should consider this trial
Good fit: Any fetus, child, or adult at risk of or diagnosed with pediatric heart disease or cardiovascular disease, including patients seen for surgery, catheterization, imaging, inpatient or outpatient Heart Institute encounters, and females carrying a fetus with suspected cardiac diagnosis, are eligible.
Not a fit: Individuals who cannot give consent because their legal guardian is unauthorized or families who choose palliative care during pregnancy are excluded and therefore unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the biorepository could accelerate discovery of genetic causes, biomarkers, and new therapies for pediatric cardiovascular disease by providing high-quality samples for many studies.
How similar studies have performed: Biorepositories and pediatric tissue banks have a track record of enabling genetic and biomarker discoveries and supporting translational cardiovascular research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cincinnati, Ohio
- Children's Hospital Medical Center, Cincinnati — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Alten — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Jeffrey Alten, MD
- Email: HIBioRepository@cchmc.org
- Phone: 513-636-2871
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.