Cachexia, Heart Failure, Sarcopenia
Conditions
Keywords
Heart failure, Sarcopenia, Cachexia
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.
Interventions
None listed
Sponsors
Aarhus University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical performance, peak VO2 | From baseline to 12 and 36 months | Change in peak oxygen uptake (peak VO2), measured in ml O2/kg/min |
| Physical performance, walking distance | From baseline to 12 and 36 months | Change in walking distance (6MWT) in meters |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Muscle tissue cellular composition | From baseline to 12 and 36 months | Change in muscle tissue cellular composition assessed by cell sorting |
| Muscle tissue mitochondrial function | From baseline to 12 and 36 months | Change in muscle mitochondrial function assessed by high-resolution respirometry |
| Body composition | From baseline to 12 and 36 months | Change in appendicular lean mass (measured in grams) and fat mass (measured in grams) |
| Insulin resistance | From baseline to 12 and 36 months | Changes in insulin resistance assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) |
| Whole body metabolism | From baseline to 12 and 36 months | Changes in circulating metabolic markers |
| Muscle metabolism | From baseline to 12 and 36 months | Changes in metabolic signature of muscle tissue assessed by liquid chromatography-high-resolution mass spectrometry |
| Daily physical activity | From baseline to 12 and 36 months | Change in daily physical activity assessed by 7-day accelerometry |
| 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) |
| 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 |
Countries
Denmark
Contacts
Primary ContactHenrik Wiggers, Prof.
Backup ContactAndreas B Tinggaard, MD
Outcome results
None listed