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Leipzig Exercise Intervention in Chronic Heart Failure and Aging (LEICA)

This study has been completed.
German Research Foundation
Information provided by:
University of Leipzig Identifier:
First received: September 9, 2005
Last updated: July 14, 2009
Last verified: July 2009

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

Condition Intervention Phase
Heart Failure Ageing Behavioral: Aerobic endurance exercise training (ergometer) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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.

Resource links provided by NLM:

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • 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:
  • Biomarkers of heart failure (including NT-proBNP)
  • Endothelial function
  • Activation of the catabolic ubiquitin-proteasome pathway

Enrollment: 120
Study Start Date: May 2005
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00176319

Universität Leipzig, Herzzentrum, Klinik für Innere Medizin/Kardiologie
Leipzig, Saxony, Germany, 04289
Sponsors and Collaborators
University of Leipzig
German Research Foundation
Principal Investigator: Rainer P Hambrecht, MD University of Leipzig, Heart Center, Dept. of Cardiology
Principal Investigator: Stephan Gielen, MD University of Leipzig - Heart Center, Dept. of Internal Medicine/Cardiology
Study Director: Volker Adams, PhD University of Leipzig, Heart Center, Dept. of Internal Medicine/Cardiology