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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects body samples and health information over time to support future research on heart disease and related conditions. It includes people with these conditions and comparison groups to help researchers learn why health improves or worsens.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • People age 16 or older with a known or suspected heart defect present at birth, other heart or blood vessel disease, or high blood pressure in the lungs.
  • People age 16 or older with a known or suspected disease of tissues that support the body, or a genetic condition.
  • Control group A: Volunteers age 16 or older who say they do not smoke and have no known history of diabetes, heart attack, stroke, heart failure, or long-term kidney disease.
  • Control group A volunteers may be family members or others coming with a patient, people who answer an ad, or other volunteers.
  • Control group B: People without a heart defect present at birth who have heart failure or high blood pressure in the lungs.

Who can't join

  • Cannot give permission to join, either personally or through a legal guardian.
  • A care provider or study researcher decides that collecting a body sample would be unsafe.
  • Stayed overnight in a hospital for a reason not related to pregnancy or childbirth and were discharged within the past 30 days.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

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