Understanding muscle loss in heart failure patients
Socioeconomic Factors and Mechanisms of Sarcopenia and Muscle Strength in Chronic Heart Failure Patients
This study looks at how factors like lifestyle and nutrition affect muscle loss in people with heart failure compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 1 site (Aarhus N) |
| Trial ID | NCT05063955 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how socioeconomic factors, daily physical activity, nutrition, and lifestyle contribute to muscle mass and function loss in patients with heart failure. It will involve 200 heart failure patients and 50 healthy controls matched by age and sex. Researchers will collect baseline data on body composition, physical capacity, nutritional status, and quality of life, along with skeletal muscle biopsies and blood samples for analysis. Follow-up visits will occur at 12 and 36 months to assess changes over time.
Who should consider this trial
Good fit: Ideal candidates include individuals with heart failure of any ejection fraction (NYHA I-IV) who can provide informed consent.
Not a fit: Patients with severe musculoskeletal or neurological disabilities, severe lung disease, or those on anticoagulant treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of muscle loss in heart failure patients, potentially enhancing their quality of life.
How similar studies have performed: While the specific interactions being studied may be novel, similar studies have shown that understanding the relationship between muscle loss and heart failure can lead to better patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ability to provide valid informed consent. 2. Heart failure with preserved, mid-range or reduced ejection fraction (NYHA I-IV) according to European Society of Cardiology guidelines. Exclusion Criteria: 1. Cancer requiring treatment (e.g. prostate cancer on watchful waiting does not exclude patients). 2. Severe musculoskeletal or neurological disability. 3. Severe lung disease with a forced expiratory volume 1 \< 40% of predicted. Treatment with anticoagulants (warfarin, apixaban, edoxaban, dabigatran and rivaroxaban) is an exclusion criterion for muscle biopsy. Patients with anticoagulant treatment will be invited to participate in the study without muscle biopsy. 4. Other comorbidities that prevent the patient from participating in the study examinations as judged by the investigator.
Where this trial is running
Aarhus N
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
Study contacts
- Study coordinator: Henrik Wiggers, Prof.
- Email: henrikwiggers@dadlnet.dk
- Phone: +45 2275 3202
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.