CompletedNot Applicable

Microvascular Dysfunction in Adults With Congenital Heart Disease and the Effect of Exercise Training

Belgium55 participantsStarted 2021-01-18

Plain-language summary

The goal of this prospective cohort study is to deepen the understanding of the pathophysiology in adults with congenital heart disease (CHD). Through this research, the investigators aim to identify potential strategies to improve the prevention and treatment of these patients. In this context, the effects of exercise training will also be assessed. The main questions it aims to answer are: * Is coronary microvascular dysfunction (MVD) present in adults with diverse types of CHD? * Is peripheral MVD present in adults with diverse types of CHD? * Are coronary and peripheral MVD correlated in adults with diverse types of CHD? * Is microvascular function correlated with inflammation and oxidative stress in adults with diverse types of CHD? * Are inflammation and oxidative stress correlated with ventricular function in adults with diverse types of CHD? * Are MVD and diminished ventricular function interrelated and associated with reduced exercise capacity in adults with diverse types of CHD? * Does exercise training in adults with CHD result in improvements in coronary and peripheral microvascular function, inflammation and oxidative stress, biventricular function, muscle strength, exercise capacity and quality of life? For the last research question, patients were randomized to receive either conventional care or home-based aerobic and strength exercise training.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * adults with congenital heart disease: as many different types of CHD as possible were incorporated * New York Heart Association (NYHA) class I-II * who visited the out-patient clinic at the Antwerp University Hospital Exclusion Criteria: * smoking * body mass index \>35 kg/m² * professional endurance athlete * the presence of macrovascular coronary artery disease * diabetes mellitus * a systemic disease (e.g., malignancies, acute and chronic inflammatory diseases in the preceding 3 months) * a contraindication for adenosine administration.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Coronary microvascular function: coronary flow reserve

Timeframe: on both study visits (at baseline and at 16 weeks)

Trial details

NCT IDNCT06715137

SponsorUniversity Hospital, Antwerp

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-31

View on ClinicalTrials.gov More Congenital Heart Defect trials