Clinical Trial

Muscle Function in Patients With Single-chamber Heart

Study acronym: Muscle in TCPC
Completed
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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.
Protocol Amendment History 2 changes
critical Completed without a posted recruiting period 2026-08-08
notable Enrollment reduced: 40 -> 34 participants 2026-08-08
Trial Details
NCT Number NCT07420660
Lead Sponsor Karolinska Institutet
Conditions Fontan Circulation
Enrollment 34 participants
Start Date 2026-02-18
Primary Completion 2026-06-08 (estimated)
Study Completion 2026-06-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-07