Heart Failure Clinical Trial
Official title:
Age-related Functional and Molecular Effects of Short-term Aerobic Endurance Training in Patients With Stable Chronic Heart Failure and Age-matched Healthy Controls.
In both ageing and heart failure progressive exercise intolerance is observed. The Leipzig
Exercise Intervention in Chronic heart failure and Aging (LEICA) study aims to investigate
how aerobic short-term training interventions affect exercise capacity, left ventricular
systolic and diastolic function, biomarkers of heart failure, skeletal muscle metabolism,
and endothelial function in chronis heart failure patients (CHF-patients) and healthy
subjects (HS) in two different age strata: Above 65 years and below 55 years.
Aim of the trial is therefore to compare the effects of aerobic exercise training in young
and old healthy subjects as well as in young and old heart failure patients. To our
knowledge this study is the first to prospectively investigate age differences of training
responses in both CHF patients and age-matched healthy controls.
Because of the extensive clinical and molecular assessment the results of this trial will be
made public in predefined substudies:
- LEICA-Echo
- LEICA-Biomarkers
- LEICA-Endothelium
- LEICA-Cardiopulmonary Exercise Function
- LEICA-Muscle
A total of 60 healthy subjects and 60 heart failure patients (in each group 30 <55 years, 30
>65 years) are prospectively randomized to either 4 weeks of aerobic ergometer training or
control group.
Before and after the intervention period maximal exercise tolerance is determined by
ergospirometry, endothelial function is measured by high-resolution A-mode ultrasound, left
ventricular function by echocardiography including tissue Doppler imaging, and thigh muscle
mass is assessed by CT. Skeletal muscle biopsies are obtained at both time-points and are
analysed for inflammatory cytokines and markers of catabolism/anabolism.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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