The Sarcopenia Study

Heart Failure Clinical Trial

Official title: The Imaging Assessment of Sarcopenia Across the Heart Failure Spectrum

Status Recruiting

Clinical Trial Summary

The goal of this cross-sectional study is to investigate the prevalence of sarcopenia in patients with Heart Failure. The main question it aims to answer is:

Whether there is a difference in the prevalence of sarcopenia across the spectrum of HFpEF (Heart failure with preserved ejection fraction) and HFrEF (heart failure with reduced ejection fraction).

This is an observational study. The participant population involves patients with heart failure with preserved ejection fraction and heart failure with reduced ejection fraction. Healthy volunteers will be recruited as controls in addition to adults with asymptomatic Type 2 Diabetes.

Participants will undergo the following:

1. Skeletal muscle mass, quality and body composition assessments using magnetic resonance imaging (MRI) and bioelectrical impedance analysis (BIA)

2. Skeletal muscle strength assessments (Dynamometer, FysioMeter, handgrip strength)

3. Skeletal muscle energetics assessment (31p-Spectroscopy pre/post-exercise recovery)

Researchers will compare Heart failure groups with healthy controls and adults with asymptomatic type 2 Diabetes to see if there are significant differences in the strength, mass and quality of skeletal muscle.

Clinical Trial Description

Heart failure is a complex condition which affects the hearts' ability to pump blood around the body properly. Due to this complexity, it often affects multiple systems in the body and can impact the quality of life. A proportion of heart failure patients also have muscle weakness, where one can feel fatigued, and weak, and may have trouble balancing and standing. To characterise muscle weakness, it is important to look at skeletal muscle mass, strength, and function. The study will focus on the prevalence of reduced muscle strength or function, using a variety of assessments within patients with heart failure. The prevalence of muscle weakness will be investigated by running assessments to look into muscle strength, a series of simple exercise tests will be run of the calf and thigh, in addition to a walking test, a balance test and a standing test to assess whole body performance. To look at the quality of skeletal muscle, a magnetic resonance imaging (MRI) and spectroscopy session will allow us to investigate the quality of the thigh muscle and the energetics in the calf. Finally, a muscle biopsy will be performed to understand differences in muscle tissue in people with different types of heart failure.

Overall, this study will provide us with unique information on skeletal muscle strength, composition and energetics within patients with heart failure, by looking at the main factors which characterise muscle weakness. ;

Related Conditions & MeSH terms

• Frailty
• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure With Reduced Ejection Fraction
• Sarcopenia
• Type 2 Diabetes

• NCT number: NCT05888688
• Study type: Observational [Patient Registry]
• Source: University of Leicester
• Contact: Sally Utton
• Phone: 44 (0)116 204 4786
• Email: su47@leicester.ac.uk
• Status: Recruiting
• Start date: December 6, 2023
• Completion date: September 1, 2026