Muscle Function in Patients With Single-chamber Heart (NCT07420660) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Muscle Function in Patients With Single-chamber Heart
40 participantsStarted 2026-02-18
Plain-language summary
Groundbreaking cardiac surgery has significantly improved survival rates for patients with single-chamber hearts. However, despite these life-saving interventions, the long-term prognosis remains concerning, with an increased risk of heart failure, sudden cardiac death, and reduced quality of life. The absence of a chamber that pumps blood to the lungs means individuals must rely on their leg muscles to passively return blood and oxygenate the lungs. Unfortunately, studies indicate reduced muscle mass and function in these patients.
The aim is to clarify the complex interplay between single-chamber circulation and muscle function, paving the way for targeted interventions such as muscle strengthening training for this unique patient group. Our hypothesis is that muscle mass and function correlate with circulatory limitations, and that muscle strengthening training could, over time, improve both muscle and circulatory function simultaneously.
The first part of the project includes tests for maximal oxygen uptake, heart and circulatory function, muscle strength, muscle mass/body composition, and quality of life in adult patients (aged 16 and over) with single-chamber hearts.
The study may ultimately lead to improved interventions and exercise recommendations that promote an active lifestyle and enhance health, circulation, and physical function in patients with single-chamber hearts.
Who can participate
Age range
16 Years – 50 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:
* Diagnosis of a Fontan circulation: individuals who have undergone the Fontan procedure with only one functioning systemic ventricle, confirmed by medical records or attending physician.
* Stable clinical status: patients should be clinically stable without significant cardiovascular or renal dysfunction as determined by clinical examinations.
* Age range: 16-50 years.
* Ability to exercise: Participants must be physically able to participate in the exercise protocol according to a preliminary medical examination.
Controls: Age and sex-matched. Healthy (no chronic diseases, assessed by health questionnaire and interview).
Exclusion Criteria:
* Recent surgery or hospitalization: individuals who have undergone cardiovascular surgery or hospitalization within six months prior to inclusion.
* Severe functional limitations: Patients with clear functional limitations unrelated to Fontan physiology, such as musculoskeletal disorders.
* Significant comorbidities: Serious non-cardiac comorbidities that may independently affect work capacity, such as advanced pulmonary disease.
* Contraindications for exercise testing: Conditions that contraindicate physical testing, such as uncontrolled cardiac arrhythmias or severe heart failure (New York Heart Association III-IV).
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
1
Relationship between anterior thigh muscle volume and peak maximal oxygen uptake in patients vs. controls
Timeframe: Baseline visit (single time-point)
2
Relationship between knee extension muscle strength and peak maximal oxygen uptake in patients vs. controls