Mechanism of Sarcopenia in Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorAarhus University Hospital
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 2 trial groupsGroup A: Chronic Heart Failure
Group B: Controls
Trial outcomes
Primary outcomes
1
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 months2
Physical performance, walking distance
Change in walking distance (6MWT) in meters
Time frame
From baseline to 12 and 36 months3
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 monthsSecondary outcomes
1
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 years2
Body composition
Change in appendicular lean mass (measured in grams) and fat mass (measured in grams)
Time frame
From baseline to 12 and 36 months3
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 months4
Muscle tissue cellular composition
Change in muscle tissue cellular composition assessed by cell sorting
Time frame
From baseline to 12 and 36 monthsSponsors and contacts
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Source ClinicalTrials.gov