NCT06217640Active, not recruiting
Multivariate Biomarker Study for Sarcopenia in Heart Failure
Towards Diagnosis of Secondary Sarcopenia as a Comorbidity in Heart Failure: a Multivariate Biomarker Approach
Source: ClinicalTrials.gov · Last updated 5 Sept 2025
Brief summary (registry, in English)
In the United Kingdom, heart failure (HF) affects about 900,000 people with 60,000 new cases annually. Up to 60% of people living with HF also experience sarcopenia, known as loss of muscle mass and strength. Sarcopenia contributes significantly to low physical capacity and exercise intolerance and worsens the prognosis of the disease and quality of life. In comparison to primary sarcopenia (age-related sarcopenia), secondary sarcopenia occurs if other factors, including malignancy or organ failure, are evident in addition to aging. Secondary sarcopenia is highly common in patients with heart failure (Sarc-HF) (prevalence is 35%-69%), and has a significantly negative impact on exercise capacity, weight-adjusted peak maximal oxygen consumption, left ventricular function, and re-hospitalization rates and mortality. In this integrated study of NHS patients with HF, the investigators aim is to identify the underlying mechanisms of muscle weakness in HF utilizing including body composition, circulating metabolites (metabolic profile), and functional tests for (1) early detection of otherwise subclinical HF, (2) diagnostic assessment of clinically manifest HF-sarcopenia, (3) the risk stratification of subjects with a suspected or confirmed diagnosis, and (4) selection of an appropriate therapeutic intervention.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 3 Oct 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- University of Liverpool
- Diseases
- Heart failure
- NCT number
- NCT06217640
What you commit to
- Study type: Observational
- Planned participants: 80
- From 1 Aug 2023 to the primary completion date, 30 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving treatment with antibiotics, probiotics, or fish oil during the last 3 months prior to inclusion.
- Treatment with immunosuppressive drugs.
- Concurrent infections, or bowel disease.
- Patients who had received cardiac resynchronization therapy during the past 6 months will not be included.
Other illness
- Major comorbidities (i.e., cancer, Alzheimer's, type 2 diabetes, chronic kidney disease).
Other
- Participants must also not be on any other clinical trial during the study.
Who the study is looking for
- Clinically diagnosed HF regardless of ejection fraction rate (both HFrEF and HFpEF).
- Age 50 years and older.
- BMI more than 18 and less than 30 kg/m\^2.
- Must be on optimal medical treatment for three months prior to inclusion.
- Do not have contraindications to providing a blood sample.
- Sufficient mental capacity to consent as determined by the researchers.
- Able to walk with or without a walker for at least 16 m.
- No objection to the researchers contacting their general practitioner and neurologist.
- No history of chronic disease and will be screened for hypertension.
- BMI more than 18 and less than 30 kg/m\^2.
- Although other cardiovascular conditions will be exclusionary, treated hypercholesterolemia and controlled hypertension will be allowed in the healthy group to allow the representation of elderly subjects within this cohort.
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liverpool University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.