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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05063955
Other study ID # 73789
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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