RecruitingNCT07477197

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

5,000 participants

Start Date

Jul 1, 2021

Study Type

OBSERVATIONAL

Conditions

Pulmonary Hypertension Connective Tissue Disease Adult Congenital Heart Disease Other Cardiovascular Conditions

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.

Eligibility

Min Age: 16 Years

Inclusion Criteria6

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.

Exclusion Criteria3

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.

Locations(1)

Children's Hospital Medical Center, Cincinnati

Cincinnati, Ohio, United States

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NCT07477197

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