Heart FailureMUSCLE-CHFNCT05063955
Mechanism of Sarcopenia in Heart Failure
An observational study of Heart Failure and Sarcopenia, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Sarcopenia, Cachexia
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Dec 2020to 31 Dec 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Andreas B Tinggaard, MD, 30272717, andreas.bugge@midt.rm.dk
Henrik Wiggers, Prof., henrikwiggers@dadlnet.dk
About this study
Official title: Socioeconomic Factors and Mechanisms of Sarcopenia and Muscle Strength in Chronic Heart Failure Patients
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.
Read the 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.
- Conditions
- Heart Failure, Sarcopenia, Cachexia
- Keywords
- Heart failure, Sarcopenia, Cachexia
- Medical subject headings
- Heart Failure, Sarcopenia, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical performance, peak VO2
Change in peak oxygen uptake (peak VO2), measured in ml O2/kg/min
Measured: From baseline to 12 and 36 months
Physical performance, walking distance
Change in walking distance (6MWT) in meters
Measured: From baseline to 12 and 36 months
Physical performance, muscle strength
Change in knee extension/flexion isokinetic strength (assessed by peak torque, Nm) and isometric strength (assessed by peak torque, Nm)
Measured: From baseline to 12 and 36 months
Secondary outcomes (10)
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
Measured: During follow-up of 10 years
Body composition
Change in appendicular lean mass (measured in grams) and fat mass (measured in grams)
Measured: From baseline to 12 and 36 months
Muscle tissue fiber types
Change in ratio between muscle fiber types (type I, IIa and IIb) assessed by immunohistochemistry
Measured: From baseline to 12 and 36 months
Muscle tissue cellular composition
Change in muscle tissue cellular composition assessed by cell sorting
Measured: From baseline to 12 and 36 months
Muscle tissue mitochondrial function
Change in muscle mitochondrial function assessed by high-resolution respirometry
Measured: From baseline to 12 and 36 months
Daily physical activity
Change in daily physical activity assessed by 7-day accelerometry
Measured: From baseline to 12 and 36 months
Insulin resistance
Changes in insulin resistance assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Measured: From baseline to 12 and 36 months
Whole body metabolism
Changes in circulating metabolic markers
Measured: From baseline to 12 and 36 months
Muscle metabolism
Changes in metabolic signature of muscle tissue assessed by liquid chromatography-high-resolution mass spectrometry
Measured: From baseline to 12 and 36 months
Symptoms
Changes in the Minnesota Living with Heart Failure Questionnaire score (range 0-105, from best to worst)
Measured: From baseline to 12 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start2 Dec 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Wiggers, Aarhus University Hospital
- Investigators
- Henrik Wiggers, Prof., Study chair, Aarhus University HospitalAndreas B Tinggaard, MD, Study chair, Aarhus University HospitalSøren P Johnsen, Prof., Study chair, Aalborg University HospitalHelene Nørrelund, Ass. Prof., Study chair, Aarhus University HospitalAnders H Larsen, MD, PhD, Study chair, Aarhus University HospitalPeter Leutscher, Prof., Study chair, Regionshospital NordjyllandPeter B Stæhr, MD, PhD, Study chair, Regionshospital NordjyllandSteen H Jørgensen, MD, Study chair, Regionshospital Nordjylland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063955
- Sponsor's protocol ID
- 73789
- Acronym
- MUSCLE-CHF
- Status last verified
- Dec 2023
- First submitted
- 1 Jun 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tinggaard AB, Sorensen L, Vissing K, Jessen N, Norrelund H, Wiggers H. Daily physical activity and prognostic implications in patients with heart failure: an accelerometer study. Clin Res Cardiol. 2025 May;114(5):616-628. doi: 10.1007/s00392-024-02508-0. Epub 2024 Sep 2.
PubMed 39222281
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socioeconomic Factors and Mechanisms of Sarcopenia and Muscle Strength in Chronic Heart Failure Patients
- ClinicalTrials.gov ID
- NCT05063955
- Acronym / sponsor ID
- MUSCLE-CHF / 73789
- Conditions
- Heart Failure, Sarcopenia, Cachexia
- Keywords
- Heart failure, Sarcopenia, Cachexia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical performance, peak VO2
Time frame: From baseline to 12 and 36 months
Change in peak oxygen uptake (peak VO2), measured in ml O2/kg/min
Physical performance, walking distance
Time frame: From baseline to 12 and 36 months
Change in walking distance (6MWT) in meters
Physical performance, muscle strength
Time frame: 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)
10 secondary outcomes
Cardiovascular events
Time frame: During follow-up of 10 years
Body composition
Time frame: From baseline to 12 and 36 months
Muscle tissue fiber types
Time frame: From baseline to 12 and 36 months
Muscle tissue cellular composition
Time frame: From baseline to 12 and 36 months
Muscle tissue mitochondrial function
Time frame: From baseline to 12 and 36 months
Daily physical activity
Time frame: From baseline to 12 and 36 months
Insulin resistance
Time frame: From baseline to 12 and 36 months
Whole body metabolism
Time frame: From baseline to 12 and 36 months
Muscle metabolism
Time frame: From baseline to 12 and 36 months
Symptoms
Time frame: From baseline to 12 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Derived from this study: PubMed 39222281Tinggaard AB, Sorensen L, Vissing K, Jessen N, Norrelund H, Wiggers H. Daily physical activity and prognostic implications in patients with heart failure: an accelerometer study. Clin Res Cardiol. 2025 May;114(5):616-628. doi: 10.1007/s00392-024-02508-0. Epub 2024 Sep 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henrik Wiggers, Prof. study chair
Aarhus University Hospital
Andreas B Tinggaard, MD study chair
Aarhus University Hospital
Søren P Johnsen, Prof. study chair
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Sarcopenia, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henrik Wiggers, Prof. (+45 2275 3202, henrikwiggers@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical performance, peak VO2 (time frame: From baseline to 12 and 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05063955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.