Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07477197

Conditions

Adult Congenital Heart Disease

Pulmonary Hypertension

Connective Tissue Disease

Other Cardiovascular Conditions

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Study Details

Brief 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 and functional status; associations between clinical characteristics and various biomarkers; and predictors of clinical outcomes.

Conditions

Adult Congenital Heart Disease

Pulmonary Hypertension

Connective Tissue Disease

Other Cardiovascular Conditions

Study ID

NCT07477197

Start date

Jul 1, 2021

Status verified date

Mar, 2026

Completion date

Jan 1, 2050

Anticipated

Primary completion date

Jan 1, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 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.
2. 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:

1. A family member or other person accompanying a patient to a clinical encounter; or,
2. A volunteer recruited via an advertisement; or,
3. Another person who volunteers to enroll in HIBR-ACHD.
3. A cohort (Control group B) of comparison subjects who do not have CHD, but have a diagnosis of heart failure or pulmonary hypertension.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

No treatment

Primary outcome measure

  • Successful establishment of biospecimen repository [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital Medical Center, Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45229

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • ACHD
  • Adult Congenital Heart Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-03-17.