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

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

July 14, 2009

Start Date ^ICMJE

May 2005

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Expression of proinflammatory cytokines
Markers of anabolism/catabolism

Change History

Complete list of historical versions of study NCT00176319 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

VO2 max
Endothelial function
Change in muscle mass

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Leipzig Exercise Intervention in Chronic Heart Failure and Aging

Official Title ^ICMJE

Age-related Functional and Molecular Effects of Short-term Aerobic Endurance Training in Patients With Stable Chronic Heart Failure and Age-matched Healthy Controls.

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Heart Failure
Ageing

Intervention ^ICMJE

Behavioral: Aerobic endurance exercise training (ergometer)

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00176319

Other Study ID Numbers ^ICMJE

GI 535/1-1, GI 535/1-1

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

University of Leipzig

Collaborators ^ICMJE

German Research Foundation

Investigators ^ICMJE

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

Information Provided By

University of Leipzig

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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