MUSCLE-CHF: Mechanism of Sarcopenia in Heart Failure

Sponsor
Aarhus University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05063955
Collaborator
(none)
500
1
156.9
3.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A total of 500 consecutive heart failure patients will be included and 100 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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Socioeconomic Factors and Mechanisms of Sarcopenia and Muscle Strength in Chronic Heart Failure Patients
    Actual Study Start Date :
    Dec 2, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2033

    Arms and Interventions

    Arm Intervention/Treatment
    Chronic Heart Failure

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

    Controls

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

    Outcome Measures

    Primary Outcome Measures

    1. Physical performance, peak VO2 [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 [From baseline to 12 and 36 months]

      Change in walking distance (6MWT) in meters

    3. Physical performance, muscle strength [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 Outcome Measures

    1. Cardiovascular events [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 [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 [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 [From baseline to 12 and 36 months]

      Change in muscle tissue cellular composition assessed by cell sorting

    5. Muscle tissue mitochondrial function [From baseline to 12 and 36 months]

      Change in muscle mitochondrial function assessed by high-resolution respirometry

    6. Daily physical activity [From baseline to 12 and 36 months]

      Change in daily physical activity assessed by 7-day accelerometry

    7. Insulin resistance [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 [From baseline to 12 and 36 months]

      Changes in circulating metabolic markers

    9. Muscle metabolism [From baseline to 12 and 36 months]

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

    10. Symptoms [From baseline to 12 and 36 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital Aarhus N Denmark 8200

    Sponsors and Collaborators

    • Aarhus University Hospital

    Investigators

    • Study Chair: Henrik Wiggers, Prof., Aarhus University Hospital
    • Study Chair: Andreas B Tinggaard, MD, Aarhus University Hospital
    • Study Chair: Søren P Johnsen, Prof., Aalborg University Hospital
    • Study Chair: Helene Nørrelund, Ass. Prof., Aarhus University Hospital
    • Study Chair: Anders H Larsen, MD, PhD, Aarhus University Hospital
    • Study Chair: Peter Leutscher, Prof., North Denmark Regional Hospital
    • Study Chair: Peter B Stæhr, MD, PhD, North Denmark Regional Hospital
    • Study Chair: Steen H Jørgensen, MD, North Denmark Regional Hospital
    • Study Chair: Niels Jessen, Prof., Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Henrik Wiggers, Professor, Aarhus University Hospital
    ClinicalTrials.gov Identifier:
    NCT05063955
    Other Study ID Numbers:
    • 73789
    First Posted:
    Oct 1, 2021
    Last Update Posted:
    Oct 1, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Henrik Wiggers, Professor, Aarhus University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 1, 2021