NCT00176319

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

July 15, 2009

Status Verified

July 1, 2009

Enrollment Period

3.6 years

First QC Date

September 9, 2005

Last Update Submit

July 14, 2009

Conditions

Heart FailureAgeing

Keywords

heart failureageing

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Biomarkers of heart failure (including NT-proBNP)

  • Endothelial function

  • Activation of the catabolic ubiquitin-proteasome pathway

Interventions

Aerobic endurance exercise training (ergometer)BEHAVIORAL

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universität Leipzig, Herzzentrum, Klinik für Innere Medizin/Kardiologie

Leipzig, Saxony, 04289, Germany

Location

Related Publications (2)

  • Gielen S, Sandri M, Kozarez I, Kratzsch J, Teupser D, Thiery J, Erbs S, Mangner N, Lenk K, Hambrecht R, Schuler G, Adams V. Exercise training attenuates MuRF-1 expression in the skeletal muscle of patients with chronic heart failure independent of age: the randomized Leipzig Exercise Intervention in Chronic Heart Failure and Aging catabolism study. Circulation. 2012 Jun 5;125(22):2716-27. doi: 10.1161/CIRCULATIONAHA.111.047381. Epub 2012 May 7.

    PMID: 22565934DERIVED

  • Sandri M, Kozarez I, Adams V, Mangner N, Hollriegel R, Erbs S, Linke A, Mobius-Winkler S, Thiery J, Kratzsch J, Teupser D, Mende M, Hambrecht R, Schuler G, Gielen S. Age-related effects of exercise training on diastolic function in heart failure with reduced ejection fraction: the Leipzig Exercise Intervention in Chronic Heart Failure and Aging (LEICA) Diastolic Dysfunction Study. Eur Heart J. 2012 Jul;33(14):1758-68. doi: 10.1093/eurheartj/ehr469. Epub 2012 Jan 19.

    PMID: 22267243DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Volker Adams, PhD

    University of Leipzig, Heart Center, Dept. of Internal Medicine/Cardiology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2008

Last Updated

July 15, 2009

Record last verified: 2009-07

Locations

DE(1)