Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2020-12-02
2033-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Controls
Age and sex matched control group. Individuals with no history of cardiovascular disease or severe lung, musculoskeletal or neurological disease.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Heart failure with preserved, mid-range or reduced ejection fraction (NYHA I-IV) according to European Society of Cardiology guidelines.
Exclusion Criteria
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.
18 Years
90 Years
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
Responsible Party
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Henrik Wiggers
Professor
Principal Investigators
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Henrik Wiggers, Prof.
Role: STUDY_CHAIR
Aarhus University Hospital
Andreas B Tinggaard, MD
Role: STUDY_CHAIR
Aarhus University Hospital
Søren P Johnsen, Prof.
Role: STUDY_CHAIR
Aalborg University Hospital
Helene Nørrelund, Ass. Prof.
Role: STUDY_CHAIR
Aarhus University Hospital
Anders H Larsen, MD, PhD
Role: STUDY_CHAIR
Aarhus University Hospital
Peter Leutscher, Prof.
Role: STUDY_CHAIR
Regionshospital Nordjylland
Peter B Stæhr, MD, PhD
Role: STUDY_CHAIR
Regionshospital Nordjylland
Steen H Jørgensen, MD
Role: STUDY_CHAIR
Regionshospital Nordjylland
Niels Jessen, Prof.
Role: STUDY_CHAIR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus N, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Andreas B Tinggaard, MD
Role: primary
Henrik Wiggers, Prof.
Role: backup
References
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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.
Other Identifiers
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73789
Identifier Type: -
Identifier Source: org_study_id