Adult Congenital Heart DiseaseHIBR-ACHDNCT07477197
Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders
An observational study of Adult Congenital Heart Disease and Pulmonary Hypertension, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
A repository of biospecimens and detailed phenotypic information collected longitudinally from adults with congenital heart disease and related conditions, with an aim to facilitate future research on biologic mechanisms of underlying disease, compensation and deterioration; biologic correlates of patient experience… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adult Congenital Heart Disease, Pulmonary Hypertension, Connective Tissue Disease
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Jan 2050
- How long will I take part?
- 10 Years
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will include individuals aged 16 years or older who are suspected of having or diagnosed with congenital heart disease (CHD), other cardiovascular disease, pulmonary hypertension, connective tissue disease, or a genetic condition; healthy volunteers, and comparison participants without CHD but with a diagnosis of heart failure or pulmonary hypertension.
Who may be able to join
- Any person ≥ 16 years-old suspected of having or diagnosed with congenital heart disease (CHD), other cardiovascular disease (CVD), pulmonary hypertension, connective tissue disease, or genetic syndrome/diagnosis.
- Additionally, a cohort (Control group A) of control subjects will be enrolled, again ≥16 years-old, self-reported non-smokers without a known history of diabetes mellitus, myocardial infarction, stroke, heart failure, or chronic kidney disease. These controls will be either:
- A family member or other person accompanying a patient to a clinical encounter; or,
- A volunteer recruited via an advertisement; or,
- Another person who volunteers to enroll in HIBR-ACHD.
- A cohort (Control group B) of comparison subjects who do not have CHD, but have a diagnosis of heart failure or pulmonary hypertension.
Who cannot join
- Unable to provide informed consent/assent personally or via a legal guardian.
- Considered unsafe to collect the biospecimen determined by either a clinical provider or an HIBR-ACHD investigator.
- Overnight hospitalization for non-obstetric reason with discharge in the prior 30 days.
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
About this study
A repository of biospecimens and detailed phenotypic information collected longitudinally from adults with congenital heart disease and related conditions, with an aim to facilitate future research on biologic mechanisms of underlying disease, compensation and deterioration; biologic correlates of patient experience and functional status; associations between clinical characteristics and various biomarkers; and predictors of clinical outcomes.
Read the detailed description
The goals of this protocol are to collect, maintain, and manage tissue specimens of various types for adults with congenital heart disease, adults with related disorders, and a set of control participants. Ultimately, we plan to approach all clinical encounters for adults (≥16 years-old) in the Heart Institute (HI) - and, in the future with additional review, the cardiology departments of additional participating sites.
We will collect extensive data on all enrolled participants, and also collect information directly from participants (e.g., via surveys about symptoms and lifestyle, patient-reported outcome metrics) at baseline and on an ongoing basis (e.g. sequential outpatient visits and procedure encounters).
- Conditions
- Adult Congenital Heart Disease, Pulmonary Hypertension, Connective Tissue Disease, Other Cardiovascular Conditions
- Keywords
- ACHD, Adult Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital, Hypertension, Pulmonary, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful establishment of biospecimen repository
Defined as the number and type of biospecimens collected and successfully linked with corresponding clinical and phenotypic data.
Measured: Day 1
Secondary outcomes (1)
Longitudinal biospecimen availability
Number of participants with repeated biospecimen collections across multiple timepoints.
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 start1 Jul 2021
- 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 Adult Congenital Heart DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sasha Opotowsky, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477197
- Sponsor's protocol ID
- 2021-0023
- Acronym
- HIBR-ACHD
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders
- ClinicalTrials.gov ID
- NCT07477197
- Acronym / sponsor ID
- HIBR-ACHD / 2021-0023
- Conditions
- Adult Congenital Heart Disease, Pulmonary Hypertension, Connective Tissue Disease, Other Cardiovascular Conditions
- Keywords
- ACHD, Adult Congenital 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
- 1 Jul 2021 (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.
A repository of biospecimens and detailed phenotypic information collected longitudinally from adults with congenital heart disease and related conditions, with an aim to facilitate future research on biologic mechanisms of underlying disease, compensation and deterioration; biologic correlates of patient experience and functional status; associations between clinical characteristics and various biomarkers; and predictors of clinical outcomes.
Detailed description
The goals of this protocol are to collect, maintain, and manage tissue specimens of various types for adults with congenital heart disease, adults with related disorders, and a set of control participants. Ultimately, we plan to approach all clinical encounters for adults (≥16 years-old) in the Heart Institute (HI) - and, in the future with additional review, the cardiology departments of additional participating sites.
We will collect extensive data on all enrolled participants, and also collect information directly from participants (e.g., via surveys about symptoms and lifestyle, patient-reported outcome metrics) at baseline and on an ongoing basis (e.g. sequential outpatient visits and procedure encounters).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will include individuals aged 16 years or older who are suspected of having or diagnosed with congenital heart disease (CHD), other cardiovascular disease, pulmonary hypertension, connective tissue disease, or a genetic condition; healthy volunteers, and comparison participants without CHD but with a diagnosis of heart failure or pulmonary hypertension.
Key inclusion criteria (6 listed)
- Any person ≥ 16 years-old suspected of having or diagnosed with congenital heart disease (CHD), other cardiovascular disease (CVD), pulmonary hypertension, connective tissue disease, or genetic syndrome/diagnosis.
- Additionally, a cohort (Control group A) of control subjects will be enrolled, again ≥16 years-old, self-reported non-smokers without a known history of diabetes mellitus, myocardial infarction, stroke, heart failure, or chronic kidney disease. These controls will be either:
- A cohort (Control group B) of comparison subjects who do not have CHD, but have a diagnosis of heart failure or pulmonary hypertension.
Key exclusion criteria (3 listed)
- Unable to provide informed consent/assent personally or via a legal guardian.
- Considered unsafe to collect the biospecimen determined by either a clinical provider or an HIBR-ACHD investigator.
- Overnight hospitalization for non-obstetric reason with discharge in the prior 30 days.
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
Successful establishment of biospecimen repository
Time frame: Day 1
Defined as the number and type of biospecimens collected and successfully linked with corresponding clinical and phenotypic data.
1 secondary outcome
Longitudinal biospecimen availability
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 17 Mar 2026.
- Individual participant dataSharing planned: No
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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
Sasha Opotowsky 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 Adult Congenital Heart Disease and Pulmonary Hypertension, 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 6 inclusion and 3 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 17 Mar 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 Sasha Opotowsky, MD (513-803-2243, sasha.opotowsky@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful establishment of biospecimen 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 17 Mar 2026.