NCT07477197

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

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

Timeline

• Start date: 2021-07-01
• Primary completion: 2050-01-01
• Completion: 2050-01-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States