Mechanism of Sarcopenia in Heart Failure

Aarhus University Hospital250 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Heart Failure Sarcopenia Cachexia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Aarhus University Hospital

Aarhus N, Denmark

RECRUITING

Outcomes

Primary Outcomes

Physical performance, peak VO2

Change in peak oxygen uptake (peak VO2), measured in ml O2/kg/min

Time frame: From baseline to 12 and 36 months

Physical performance, walking distance

Change in walking distance (6MWT) in meters

Time frame: From baseline to 12 and 36 months

Physical performance, muscle strength

Change in knee extension/flexion isokinetic strength (assessed by peak torque, Nm) and isometric strength (assessed by peak torque, Nm)

Time frame: From baseline to 12 and 36 months

Secondary Outcomes

Cardiovascular events

Incidence of a composite endpoint of death, hospitalization with worsening of heart failure other cardiovascular events (myocardial infarction, unstable angina, revascularization and stroke) and non-cardiovascular hospitalizations

Time frame: During follow-up of 10 years

Body composition

Change in appendicular lean mass (measured in grams) and fat mass (measured in grams)

Time frame: From baseline to 12 and 36 months

Muscle tissue fiber types

Change in ratio between muscle fiber types (type I, IIa and IIb) assessed by immunohistochemistry

Time frame: From baseline to 12 and 36 months

Muscle tissue cellular composition

Change in muscle tissue cellular composition assessed by cell sorting

Time frame: From baseline to 12 and 36 months