Heart Institute Biobank and Registry for Adults with Congenital Heart Disease and Related Conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The program enrolls adults (age ≥16) with congenital heart disease and related disorders, along with two comparison control groups, and collects biospecimens and detailed clinical data on an ongoing basis. Participants provide samples at clinical encounters and complete surveys and patient-reported outcome measures to capture symptoms, lifestyle, and functional status. All specimens and linked phenotypic data are stored longitudinally to support future research on biological mechanisms, biomarkers, and predictors of clinical outcomes. Enrollment is conducted at the Heart Institute with plans for possible expansion to additional cardiology sites after review.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital Medical Center, Cincinnati
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Sasha Opotowsky — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Sasha Opotowsky, MD
• Email: sasha.opotowsky@cchmc.org
• Phone: 513-803-2243

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Levosimendan to see if it helps the heart after PEA in CTEPH

  This small randomized trial tests whether giving levosimendan around surgery helps reduce pulmonary artery pressure and support right heart function after pulmonary endarterectomy for CTEPH.

  Recruiting Meshalkin Research Institute of Pathology of Circulation · Novosibirsk · NCT07914933

• Early treatment with inhaled treprostinil for exercise-induced pulmonary hypertension in ILD or CTD

  This study tests whether inhaled treprostinil added to standard care can improve exercise-related lung blood flow and function in adults with ILD or CTD who develop pulmonary hypertension during exercise.

  Recruiting at 2 sites Early Phase 1 Valley Health System · Paramus, New Jersey and 1 other locations · NCT07837830

• Brazilian Portuguese version of EmPHasis-10 for pulmonary hypertension

  This study tests a Brazilian Portuguese version of the EmPHasis-10 questionnaire to see if it reliably measures quality of life in adults with pulmonary hypertension in Porto Alegre, Brazil.

  Recruiting Hospital de Clinicas de Porto Alegre · Porto Alegre · NCT07822997

• Inhaled mosliciguat for pulmonary hypertension in interstitial lung disease (PH-ILD) patients

  This study tests inhaled mosliciguat versus placebo in people with PH-ILD to see if it helps with their condition.

  Recruiting at 3 sites Phase 3 Pulmovant, Inc. · Kissimmee, Florida and 2 other locations · NCT07816185

• Pulmonary Artery Denervation for Pulmonary Hypertension After M-TEER

  This study tests whether PADN can help people with pulmonary hypertension after M-TEER compared with standard medical therapy.

  Recruiting Early Phase 1 Xiamen Cardiovascular Hospital, Xiamen University · Xiamen, Fujian · NCT07662655

• Risk Factor Assessment for Acute Pulmonary Hypertension Crisis

  This study tests how to identify people with pulmonary hypertension who are at risk of a sudden, life-threatening crisis.

  Recruiting at 4 sites Peking Union Medical College Hospital · Guangzhou, Guangdong and 3 other locations · NCT07653958

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.