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

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

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.

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).

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.