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

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ClinicalTrials.gov Identifier: NCT00176319
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 15, 2009
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
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

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : May 2005
Actual Primary Completion Date : December 2008

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Primary Outcome Measures :
  1. Improvement in functional exercise capacity (as measured by cardiopulmonary exercise testing)
  2. Echocardiography: Improvement in left ventricular diastolic function as assessed by tissue Doppler (E/E' ratio)

Secondary Outcome Measures :
  1. Biomarkers of heart failure (including NT-proBNP)
  2. Endothelial function
  3. Activation of the catabolic ubiquitin-proteasome pathway


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176319


Locations
Germany
Universität Leipzig, Herzzentrum, Klinik für Innere Medizin/Kardiologie
Leipzig, Saxony, Germany, 04289
Sponsors and Collaborators
University of Leipzig
German Research Foundation
Investigators
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