Leipzig Exercise Intervention in Chronic Heart Failure and Aging

Heart Failure Clinical Trial

— LEICA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00176319
• Other study ID #: GI 535/1-1
• Secondary ID: GI 535/1-1
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: July 14, 2009
• Start date: May 2005

Study information

• Verified date: July 2009
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Ageing
• Heart Failure

Intervention

Behavioral:
• Aerobic endurance exercise training (ergometer)

Locations

Country	Name	City	State
Germany	Universität Leipzig, Herzzentrum, Klinik für Innere Medizin/Kardiologie	Leipzig	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in functional exercise capacity (as measured by cardiopulmonary exercise testing)			No
Primary	Echocardiography: Improvement in left ventricular diastolic function as assessed by tissue Doppler (E/E' ratio)			No
Secondary	Biomarkers of heart failure (including NT-proBNP)
Secondary	Endothelial function
Secondary	Activation of the catabolic ubiquitin-proteasome pathway