Mechanism of Sarcopenia in Heart Failure

Heart Failure Clinical Trial

— MUSCLE-CHF  

Official title:

Socioeconomic Factors and Mechanisms of Sarcopenia and Muscle Strength in Chronic Heart Failure Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063955
• Other study ID #: 73789
• Status: Recruiting
• Start date: December 2, 2020
• Est. completion date: December 31, 2033

Study information

• Verified date: December 2023
• Source: Aarhus University Hospital
• Contact: Henrik Wiggers, Prof.
• Phone: +45 2275 3202
• Email: henrikwiggers[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Heart Failure
• Sarcopenia

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical performance, peak VO2	Change in peak oxygen uptake (peak VO2), measured in ml O2/kg/min	From baseline to 12 and 36 months
Primary	Physical performance, walking distance	Change in walking distance (6MWT) in meters	From baseline to 12 and 36 months
Primary	Physical performance, muscle strength	Change in knee extension/flexion isokinetic strength (assessed by peak torque, Nm) and isometric strength (assessed by peak torque, Nm)	From baseline to 12 and 36 months
Secondary	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	During follow-up of 10 years
Secondary	Body composition	Change in appendicular lean mass (measured in grams) and fat mass (measured in grams)	From baseline to 12 and 36 months
Secondary	Muscle tissue fiber types	Change in ratio between muscle fiber types (type I, IIa and IIb) assessed by immunohistochemistry	From baseline to 12 and 36 months
Secondary	Muscle tissue cellular composition	Change in muscle tissue cellular composition assessed by cell sorting	From baseline to 12 and 36 months
Secondary	Muscle tissue mitochondrial function	Change in muscle mitochondrial function assessed by high-resolution respirometry	From baseline to 12 and 36 months
Secondary	Daily physical activity	Change in daily physical activity assessed by 7-day accelerometry	From baseline to 12 and 36 months
Secondary	Insulin resistance	Changes in insulin resistance assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	From baseline to 12 and 36 months
Secondary	Whole body metabolism	Changes in circulating metabolic markers	From baseline to 12 and 36 months
Secondary	Muscle metabolism	Changes in metabolic signature of muscle tissue assessed by liquid chromatography-high-resolution mass spectrometry	From baseline to 12 and 36 months
Secondary	Symptoms	Changes in the Minnesota Living with Heart Failure Questionnaire score (range 0-105, from best to worst)	From baseline to 12 and 36 months