Investigating muscle weakness in heart failure patients
The Imaging Assessment of Sarcopenia Across the Heart Failure Spectrum
This study is trying to see how common muscle weakness is in heart failure patients with different types of heart function to better understand how it affects their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT05888688 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence of sarcopenia in patients with heart failure, specifically comparing those with preserved ejection fraction (HFpEF) and reduced ejection fraction (HFrEF). Participants will undergo various assessments, including magnetic resonance imaging (MRI) and bioelectrical impedance analysis (BIA) to evaluate skeletal muscle mass and quality, as well as strength tests using dynamometers and handgrip strength measurements. The study will also include exercise tests to assess overall body performance and muscle energetics. By characterizing muscle weakness in heart failure patients, the study seeks to provide valuable insights into the relationship between heart failure and muscle health.
Who should consider this trial
Good fit: Ideal candidates include adults aged 65 and older with stable heart failure (HFpEF or HFrEF) or healthy volunteers aged 18 and older.
Not a fit: Patients with absolute contraindications to MRI or those unable to perform the required physical assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of muscle weakness in heart failure patients, potentially enhancing their quality of life.
How similar studies have performed: While the investigation of sarcopenia in heart failure is an emerging area, similar studies have shown promising results in understanding muscle health in various populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Leicester, Leicestershire
- University Hospitals of Leicester NHS Trust — Leicester, Leicestershire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Gerry McCann, BSc, MB, ChB, MRCP, MD — University of Leicester (UoL)
- Study coordinator: Sally Utton
- Email: su47@leicester.ac.uk
- Phone: 44 (0)116 204 4786
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.