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

July 14, 2009 updated by: University of Leipzig

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony
      • Leipzig, Saxony, Germany, 04289
        • Universität Leipzig, Herzzentrum, Klinik für Innere Medizin/Kardiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Endothelial function
Biomarkers of heart failure (including NT-proBNP)
Activation of the catabolic ubiquitin-proteasome pathway

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

July 15, 2009

Last Update Submitted That Met QC Criteria

July 14, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI 535/1-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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