Heart FailurePhase 2LEICANCT00176319
Leipzig Exercise Intervention in Chronic Heart Failure and Aging
A Phase 2 study testing Aerobic endurance exercise training (ergometer) in people with Heart Failure and Ageing, run by University of Leipzig at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Ageing
- What is being tested?
- Aerobic endurance exercise training (ergometer)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- May 2005to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universität Leipzig, Herzzentrum, Klinik für Innere Medizin/Kardiologie
Leipzig, Saxony, 04289
About this study
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.
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.
Read more
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
Read the 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.
- Conditions
- Heart Failure, Ageing
- Being tested
- Aerobic endurance exercise training (ergometer)
- Keywords
- heart failure, ageing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic endurance exercise training (ergometer)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Investigators
- Rainer P Hambrecht, MD, Principal investigator, University of Leipzig, Heart Center, Dept. of CardiologyStephan Gielen, MD, Principal investigator, University of Leipzig - Heart Center, Dept. of Internal Medicine/CardiologyVolker Adams, PhD, Study director, University of Leipzig, Heart Center, Dept. of Internal Medicine/Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176319
- Sponsor's protocol ID
- GI 535/1-1
- Other IDs
- GI 535/1-1
- Acronym
- LEICA
- Status last verified
- Jul 2009
- First submitted
- 9 Sep 2005
- Last updated
- 15 Jul 2009
- Results posted
- No
Publications
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.
PubMed 22565934Sandri 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.
PubMed 22267243
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00176319
- Acronym / sponsor ID
- LEICA / GI 535/1-1
- Conditions
- Heart Failure, Ageing
- Keywords
- heart failure, ageing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- May 2005
- Primary completion
- Dec 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (8 listed)
- COLD
- cardiac decompensation <3 months
- ventricular arrhythmias >Lown IVb
- myocardial infarction < 4 weeks
- valvular heart disease >II°
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic endurance exercise training (ergometer) | Behavioural | – |
Primary outcome
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)
3 secondary outcomes
Biomarkers of heart failure (including NT-proBNP)
Endothelial function
Activation of the catabolic ubiquitin-proteasome pathway
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2009.
- Derived from this study: PubMed 22565934Gielen 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.
- Derived from this study: PubMed 22267243Sandri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer P Hambrecht, MD principal investigator
University of Leipzig, Heart Center, Dept. of Cardiology
Stephan Gielen, MD principal investigator
University of Leipzig - Heart Center, Dept. of Internal Medicine/Cardiology
Volker Adams, PhD study director
University of Leipzig, Heart Center, Dept. of Internal Medicine/Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerobic endurance exercise training (ergometer) in people with Heart Failure and Ageing, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in functional exercise capacity (as measured by cardiopulmonary exercise testing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00176319, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2009.