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NCT Number: NCT00176319

Leipzig Exercise Intervention in Chronic Heart Failure and Aging

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

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Key information

Conditions

Heart Failure Ageing Cardiovascular Diseases Heart Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universität Leipzig, Herzzentrum, Klinik für Innere Medizin/Kardiologie

Leipzig, Saxony, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic endurance exercise training (ergometer)

Behavioral

Primary outcomes

  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 outcomes

  1. Biomarkers of heart failure (including NT-proBNP)

  2. Endothelial function

  3. Activation of the catabolic ubiquitin-proteasome pathway

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • German Research Foundation

Registry information

Official study 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.

Acronym: LEICA

Important dates

Study start
2005
Primary completion
2008
First posted
Sep 15, 2005
Registry last updated
Jul 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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