Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders

NCT07477197 | Recruiting

• 1 other identifier: 2021-0023
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Keywords

ACHD; Adult Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Successful establishment of biospecimen repository

  Defined as the number and type of biospecimens collected and successfully linked with corresponding clinical and phenotypic data.

  Day 1

Secondary Outcomes (1)

• Longitudinal biospecimen availability

  Day 1

Other Outcomes (2)

• Event-based biospecimen collection completeness

  Day 1

• Data completeness of linked clinical phenotypes

  Day 1

Study Arms (1)

No treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Children's Hospital Medical Center, Cincinnati

Cincinnati, Ohio, 45229, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue ascertainment will include but is not limited to the collection of whole blood, saliva, and/or urine, obtained during a clinical encounter or another scheduled appointment as discussed above.

MeSH Terms

Conditions

Heart Defects, Congenital; Hypertension, Pulmonary; Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sasha Opotowsky

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sasha Opotowsky, MD

CONTACT

513-803-2243; sasha.opotowsky@cchmc.org

Lindsay Fist

CONTACT

lindsay.fist@cchmc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 17, 2026
• Study Start: July 1, 2021
• Primary Completion (Estimated): January 1, 2050
• Study Completion (Estimated): January 1, 2050
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)