Mechanism of Sarcopenia in Heart Failure

Last updated: December 19, 2023
Sponsor: Aarhus University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Heart Failure

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT05063955
73789
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Cancer requiring treatment (e.g. prostate cancer on watchful waiting does not excludepatients).
  2. Severe musculoskeletal or neurological disability.
  3. Severe lung disease with a forced expiratory volume 1 < 40% of predicted. Treatmentwith anticoagulants (warfarin, apixaban, edoxaban, dabigatran and rivaroxaban) is anexclusion criterion for muscle biopsy. Patients with anticoagulant treatment will beinvited to participate in the study without muscle biopsy.
  4. Other comorbidities that prevent the patient from participating in the studyexaminations as judged by the investigator.

Study Design

Total Participants: 250
Study Start date:
December 02, 2020
Estimated Completion Date:
December 31, 2033

Study 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.

Connect with a study center

  • Aarhus University Hospital

    Aarhus N, 8200
    Denmark

    Active - Recruiting

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