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

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00176319
First received: September 9, 2005
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Improvement in functional exercise capacity (as measured by cardiopulmonary exercise testing) [ Designated as safety issue: No ]
  • Echocardiography: Improvement in left ventricular diastolic function as assessed by tissue Doppler (E/E' ratio) [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of Leipzig

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00176319     History of Changes
Other Study ID Numbers: GI 535/1-1, GI 535/1-1
Study First Received: September 9, 2005
Last Updated: July 14, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
heart failure
ageing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013