| NCT ID | NCT05888688 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leicester |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-12-06 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-12-06 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Gerry McCann, BSc, MB, ChB, MRCP, MD
PRINCIPAL INVESTIGATOR
University of Leicester (UoL)
Frequently Asked Questions
Who can join the NCT05888688 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05888688 currently recruiting?
Yes, NCT05888688 is actively recruiting participants. Contact the research team at su47@leicester.ac.uk for enrollment information.
Where is the NCT05888688 trial being conducted?
This trial is being conducted at Leicester, United Kingdom.
Who is sponsoring the NCT05888688 clinical trial?
NCT05888688 is sponsored by University of Leicester. The principal investigator is Gerry McCann, BSc, MB, ChB, MRCP, MD at University of Leicester (UoL). The trial plans to enroll 80 participants.
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