NCT07478354 · Children's Hospital Medical Center, Cincinnati
Heart Institute BioRepository (HIBR) for Pediatric Heart Disease
(HIBR)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Cincinnati, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations