Leipzig Exercise Intervention in Chronic Heart Failure and Aging

Phase 2

Completed

• Conditions: Heart Failure; Ageing

• Registration Number: NCT00176319
• Lead Sponsor: University of Leipzig

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2008-12
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-14
• Last Update Posted: 2009-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Group 1: Healthy subjects

• normal left ventricular ejection fraction (EF) >55%
• normal coronary artery disease (cardiac catheterization)

Group 2: CHF patients

• reduced left ventricular ejection fraction (EF) <40%
• stable clinical condition (NYHA II-III)

Exclusion Criteria

• COLD
• cardiac decompensation <3 months
• ventricular arrhythmias >Lown IVb
• myocardial infarction < 4 weeks
• valvular heart disease >II°
• insulin-dependent diabetes mellitus
• arterial hypertension
• orthopedic conditions prohibiting training participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement in functional exercise capacity (as measured by cardiopulmonary exercise testing)
Echocardiography: Improvement in left ventricular diastolic function as assessed by tissue Doppler (E/E' ratio)

Secondary Outcome Measures

Name	Time	Method
Biomarkers of heart failure (including NT-proBNP)
Endothelial function
Activation of the catabolic ubiquitin-proteasome pathway

Trial Locations

Locations (1)

Universität Leipzig, Herzzentrum, Klinik für Innere Medizin/Kardiologie; 🇩🇪 Leipzig, Saxony, Germany