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RECRUITING

NCT05888688

The Sarcopenia Study

Sponsor: University of Leicester

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2023-12-06

Completion Date

2026-09-01

Last Updated

2023-12-19

Healthy Volunteers

Yes

Conditions

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

Inclusion Criteria: Heart Failure (HF) Patients: Stage A/B HFpEF 1. Established clinical diagnosis of HFpEF (EF\>50%) 2. Clinically stable for ≥ 3 months (no admissions to hospital) 3. Age ≥65 4. Willing to provide written consent for participation in the study. HF Patients: Stage C/D HFpEF and HFrEF 1. Established clinical diagnosis of HFpEF (EF\>50%) OR HFrEF (EF\<40%) 2. Clinically stable for ≥ 3 months (no admissions to hospital) 3. Age ≥65 4. Willing to provide written consent for participation in the study. Healthy volunteers 1\. Age \>18 2. Able to provide written informed consent Asymptomatic T2D 1. Male or female, aged ≥18 and ≤75 years. 2. Diagnosis of stable T2D (determined by i) formal diagnosis in primary care physician case records, ii) a record of diagnostic oral glucose tolerance test OR glycated haemoglobin level ≥6.5%). Exclusion criteria: Heart failure 1. Absolute contraindication to MRI 2. Inability to walk/undertake the 6-Minute Walk Test (6MWT) 3. Neuromuscular disorders that may impact skeletal muscle assessment, such as motor neurone disease, multiple sclerosis, skeletal muscle myopathies and myositis 4. Regular or intermittent oral corticosteroid use 5. Untreated hyper or hypothyroidism 6. Heart failure-related hospitalisations in the last 3 months Healthy volunteers 1. Previous or current signs of HF 2. Risk factors for the development of HF, such as hypertension, diabetes Mellitus or coronary artery disease Asymptomatic Type 2 Diabetes Mellitus (T2D) 1. Angina pectoris or limiting dyspnoea (\>NYHA II) 2. Major atherosclerotic disease: Symptomatic CAD, history of MI, previous revascularisation, stroke/transient ischaemic attack or symptomatic peripheral vascular disease. 3. Atrial fibrillation or flutter. 4. Moderate to severe valvular heart disease. 5. History of heart failure or cardiomyopathy. 6. Type 1 diabetes mellitus (T1DM). 7. Low fasting C-peptide levels suggestive of adult-onset T1DM. 8. Stage III-V renal disease (estimated glomerular filtration rate ≤30ml/min/1.73m2). 9. Absolute contraindications to MRI.

Locations (1)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom