Clinical trial NCT05063955: Mechanism of Sarcopenia in Heart Failure
Official title: Socioeconomic Factors and Mechanisms of Sarcopenia and Muscle Strength in Chronic Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Sarcopenia
Cachexia
Keywords: Heart failure
Sarcopenia
Cachexia
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical performance, peak VO2
timeFrame: From baseline to 12 and 36 months
measure: Physical performance, walking distance
timeFrame: From baseline to 12 and 36 months
measure: Physical performance, muscle strength
timeFrame: From baseline to 12 and 36 months
Secondary outcomes:
measure: Cardiovascular events
timeFrame: During follow-up of 10 years
measure: Body composition
timeFrame: From baseline to 12 and 36 months
measure: Muscle tissue fiber types
timeFrame: From baseline to 12 and 36 months
measure: Muscle tissue cellular composition
timeFrame: From baseline to 12 and 36 months
measure: Muscle tissue mitochondrial function
timeFrame: From baseline to 12 and 36 months
measure: Daily physical activity
timeFrame: From baseline to 12 and 36 months
measure: Insulin resistance
timeFrame: From baseline to 12 and 36 months
measure: Whole body metabolism
timeFrame: From baseline to 12 and 36 months
measure: Muscle metabolism
timeFrame: From baseline to 12 and 36 months
measure: Symptoms
timeFrame: From baseline to 12 and 36 months
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Henrik Wiggers, Prof.
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Andreas B Tinggaard, MD
role: STUDY_CHAIR
affiliation: Aalborg University Hospital
name: Søren P Johnsen, Prof.
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Helene Nørrelund, Ass. Prof.
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Anders H Larsen, MD, PhD
role: STUDY_CHAIR
affiliation: Regionshospital Nordjylland
name: Peter Leutscher, Prof.
role: STUDY_CHAIR
affiliation: Regionshospital Nordjylland
name: Peter B Stæhr, MD, PhD
role: STUDY_CHAIR
affiliation: Regionshospital Nordjylland
name: Steen H Jørgensen, MD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Niels Jessen, Prof.
role: STUDY_CHAIR
References: