Muscle Function in Patients With Single-chamber Heart
Key facts
- Who runs it
- Karolinska Institutet
- Where
- Sweden1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 34 people enrolled
- Started
- 18 Feb 2026
- Ended
- 8 Jun 2026
- Type of study
- Observational, 2 groups
- Record updated
- 7 August 2026
Who can take part
- Age
- 16 years to 50 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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)
Who cannot take part
- 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)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Patients
- Controls
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Importance of Muscle Function for Patients With Single-chamber Heart
- Record updated
- 7 August 2026