Mechanism of Sarcopenia in Heart Failure (MUSCLE-CHF)

Aarhus University Hospital

Status: Enrolling

Conditions: Cachexia; Heart Failure; Sarcopenia

Study type: Observational

Funder types: Other

Identifiers

NCT05063955

73789

Details and patient eligibility

About

The aim of the study is to provide information on the interaction between socioeconomic factors, daily physical activity, nutrition and lifestyle on loss of muscle mass and muscle function in patients with heart failure.

Full description

A total of 200 consecutive heart failure patients will be included and 50 age and sex-matched individuals with no history of cardiovascular disease will serve as controls.

Baseline variables of body composition, physical capacity, daily physical activity, nutritional status, quality of life, socioeconomic status and insulin resistance will be obtained along with a skeletal muscle tissue biopsy and blood samples for laboratory analyses.

Baseline variables from heart failure patients will be compared to healthy controls.

Patients and controls will be invited to follow-up visits at 12 and 36 months. Changes in baseline variables will be analyzed.

Events will be identified through national registries.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

250 participants in 2 patient groups

Chronic Heart Failure

Description:

Patients with heart failure with preserved, mid-range or reduced ejection fraction (NYHA I-IV) according to European Society of Cardiology guidelines.

Controls

Description:

Age and sex matched control group. Individuals with no history of cardiovascular disease or severe lung, musculoskeletal or neurological disease.