Cardiovascular Diseases (CVD)HIBRNCT07478354
Heart Institute BioRepository (HIBR) for Pediatric Heart Disease
An observational study of Cardiovascular Diseases (CVD), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases (CVD)
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2012to 1 Jan 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include any fetus, child, or adult who is at risk for or diagnosed with pediatric heart disease (PHD) or cardiovascular disease (CVD). Eligible participants include all Heart Institute patients across surgical, cardiac catheterization, advanced imaging, inpatient, perinatal, and outpatient clinical encounters. In addition, any pregnant individual carrying a fetus with a suspected cardiac diagnosis will be included.
Who may be able to join
- 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
Who cannot join
- Legal guardian unauthorized to consent
- Families who choose Palliative care during pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lindsay Fist contact
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Medical Center, Cincinnati
Cincinnati, Ohio, 45229
Jeffrey Alten, MD, 513-636-2871, HIBioRepository@cchmc.org
Lindsay Fist, HIBioRepository@cchmc.org
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases (CVD)
- Keywords
- cardiovascular disease, Pediatric Heart disease
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological sample collection for repository
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.
Measured: Day 1
Secondary outcomes (1)
Data collection for repository
Demographic information, outcomes, risk factor, and other clinical data
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start27 Jan 2012
- Primary completion1 Jan 2050 (estimated)
- Study completion1 Jan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)Studies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Alten, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478354
- Sponsor's protocol ID
- 2011-2856
- Acronym
- HIBR
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identifiable information (Name/Medical Record Number), geo-coding, or a limited dataset can be provided to CCHMC investigators (Date of Birth/Death, Date of Procedure, Diagnosis, Age, etc.). Identifiable information will not be provided to outside organizations, only a limited data set or geo-coding may be provided if deemed necessary. This will only be provided once the investigator has IRB approval.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Institute BioRepository (HIBR) for Pediatric Heart Disease
- ClinicalTrials.gov ID
- NCT07478354
- Acronym / sponsor ID
- HIBR / 2011-2856
- Conditions
- Cardiovascular Diseases (CVD)
- Keywords
- cardiovascular disease, Pediatric Heart disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 27 Jan 2012 (actual)
- Primary completion
- 1 Jan 2050 (estimated)
- Study completion
- 1 Jan 2050 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include any fetus, child, or adult who is at risk for or diagnosed with pediatric heart disease (PHD) or cardiovascular disease (CVD). Eligible participants include all Heart Institute patients across surgical, cardiac catheterization, advanced imaging, inpatient, perinatal, and outpatient clinical encounters. In addition, any pregnant individual carrying a fetus with a suspected cardiac diagnosis will be included.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Legal guardian unauthorized to consent
- Families who choose Palliative care during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Data collection for repository
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Yes. Identifiable information (Name/Medical Record Number), geo-coding, or a limited dataset can be provided to CCHMC investigators (Date of Birth/Death, Date of Procedure, Diagnosis, Age, etc.). Identifiable information will not be provided to outside organizations, only a limited data set or geo-coding may be provided if deemed necessary. This will only be provided once the investigator has IRB approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lindsay Fist contact
Jeffrey Alten principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases (CVD), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Alten, MD (513-636-2871, HIBioRepository@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological sample collection for repository (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.