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NCT Number: NCT05063955

Mechanism of Sarcopenia in Heart Failure

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.

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Key information

Conditions

Heart Failure Atrophy Body Weight Body Weight Changes Cachexia Cardiovascular Diseases Heart Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Thinness Weight Loss

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide valid informed consent.
  • Heart failure with preserved, mid-range or reduced ejection fraction (NYHA I-IV) according to European Society of Cardiology guidelines.

Exclusion criteria

  • Cancer requiring treatment (e.g. prostate cancer on watchful waiting does not exclude patients).
  • Severe musculoskeletal or neurological disability.
  • 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.
  • Other comorbidities that prevent the patient from participating in the study examinations as judged by the investigator.

Treatment and study plan

Primary outcomes

  1. Physical performance, peak VO2

    Time frame: From baseline to 12 and 36 months

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

  2. Physical performance, walking distance

    Time frame: From baseline to 12 and 36 months

    Change in walking distance (6MWT) in meters

  3. Physical performance, muscle strength

    Time frame: From baseline to 12 and 36 months

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

Secondary outcomes

  1. Cardiovascular events

    Time frame: During follow-up of 10 years

    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

  2. Body composition

    Time frame: From baseline to 12 and 36 months

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

  3. Muscle tissue fiber types

    Time frame: From baseline to 12 and 36 months

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

  4. Muscle tissue cellular composition

    Time frame: From baseline to 12 and 36 months

    Change in muscle tissue cellular composition assessed by cell sorting

  5. Muscle tissue mitochondrial function

    Time frame: From baseline to 12 and 36 months

    Change in muscle mitochondrial function assessed by high-resolution respirometry

  6. Daily physical activity

    Time frame: From baseline to 12 and 36 months

    Change in daily physical activity assessed by 7-day accelerometry

  7. Insulin resistance

    Time frame: From baseline to 12 and 36 months

    Changes in insulin resistance assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  8. Whole body metabolism

    Time frame: From baseline to 12 and 36 months

    Changes in circulating metabolic markers

  9. Muscle metabolism

    Time frame: From baseline to 12 and 36 months

    Changes in metabolic signature of muscle tissue assessed by liquid chromatography-high-resolution mass spectrometry

  10. Symptoms

    Time frame: From baseline to 12 and 36 months

    Changes in the Minnesota Living with Heart Failure Questionnaire score (range 0-105, from best to worst)

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas B Tinggaard, MD

CONTACT

[email protected]

+45 3027 2717

Henrik Wiggers, Prof.

CONTACT

[email protected]

+45 2275 3202

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

Socioeconomic Factors and Mechanisms of Sarcopenia and Muscle Strength in Chronic Heart Failure Patients

Acronym: MUSCLE-CHF

Important dates

Study start
2020
Primary completion
2026
Study completion
2033
First posted
Oct 1, 2021
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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