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NCT Number: NCT07478354

Heart Institute BioRepository (HIBR) for Pediatric Heart Disease

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Medical Center, Cincinnati

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Location contact

Jeffrey Alten

PRINCIPAL_INVESTIGATOR

Jeffrey Alten, MD

CONTACT

[email protected]

513-636-2871

Lindsay Fist

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Biological sample collection for repository

    Time frame: 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 outcomes

  1. Data collection for repository

    Time frame: Day 1

    Demographic information, outcomes, risk factor, and other clinical data

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey Alten, MD

CONTACT

[email protected]

513-636-2871

Lindsay Fist

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Acronym: HIBR

Important dates

Study start
2012
Primary completion
2050
Study completion
2050
First posted
Mar 17, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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