Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:22 AM
Study NCT ID:
NCT07420660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Function in Patients With Single-chamber Heart
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Importance of Muscle Function for Patients With Single-chamber Heart
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Muscle in TCPC
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: