Understanding muscle loss in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Aarhus University Hospital
  Aarhus N, Denmark Recruiting

Study contacts

• Study coordinator: Henrik Wiggers, Prof.
• Email: henrikwiggers@dadlnet.dk
• Phone: +45 2275 3202

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.