Heart Institute BioRepository (HIBR) for Pediatric Heart Disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07478354

Acronym

HIBR

Enrollment

5000

Registered

2026-03-17

Start date

2012-01-27

Completion date

2050-01-01

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases (CVD)

Keywords

cardiovascular disease, Pediatric Heart disease

Brief summary

The purpose of this protocol is to redefine the Heart Institute BioRepository (HIBR) to facilitate Investigator-initiated and programmatic basic, translational, clinical and outcomes research. For the purposes of this protocol, "tissue" will refer to any gross specimen obtained from a patient, including but not limited to blood, cardiovascular tissue, urine, saliva, and other tissues and bodily fluids, including explanted non-human prosthetics or grafts. In this context, "tissue" is synonymous with "sample" or "specimen." A "BioRepository" functions to systematically collect, maintain and govern tissue specimens.

Detailed description

The HIBR is a prospective and retrospective observational repository. Designed as a core facility for Heart Institute investigators, it will grow into an institutional and eventually national resource. Located in dedicated research space within the Heart Institute, HIBR acquires, processes, organizes, and stores tissue and blood samples for current and future studies. Whole blood is used for DNA isolation, and the repository can perform limited wet-bench functions, including plasma isolation and B-lymphocyte transformation to generate immortalized cell lines and preserve genomic material. Samples may be collected at multiple time points, including during surgery, outpatient clinic visits, the perinatal period, and cardiac catheterizations, to capture comprehensive biological data across clinical encounters.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Biological sample collection for repository	Day 1	Blood samples will be collected for preparation of plasma and serum, extraction of DNA and isolation of circulating cells. Future analysis includes genotype-phenotype relationships using blood-tissue pairs.

Secondary

Measure	Time frame	Description
Data collection for repository	Day 1	Demographic information, outcomes, risk factor, and other clinical data

Countries

United States

Contacts

CONTACTJeffrey Alten, MD

HIBioRepository@cchmc.org513-636-2871

CONTACTLindsay Fist

HIBioRepository@cchmc.org

PRINCIPAL_INVESTIGATORJeffrey Alten

Children's Hospital Medical Center, Cincinnati

Outcome results