Dilated CardiomyopathyCHFNCT00934609
Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure
A study testing Endurance training in people with Dilated Cardiomyopathy and Chronic Heart Failure, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
The study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dilated Cardiomyopathy, Chronic Heart Failure
- What is being tested?
- Endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic heart failure NYHA stage 2 and 3
Who cannot join
- Valvular disease
- recent decompensation
- Other complaints that might interfere with ergometer exercise
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Sports- and Preventive Medicine, Saarland University
Saarbrücken, Saarland, 66123
About this study
Official title: Effects of 12-weeks Endurance Training in Patients With Chronic Heart Failure Due to Dilated Cardiomyopathy
The study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure
- Conditions
- Dilated Cardiomyopathy, Chronic Heart Failure
- Being tested
- Endurance training
- Keywords
- Exercise, heart failure, dilated cardiomyopathy, Endurance training
- Medical subject headings
- Cardiomyopathy, Dilated, Motor Activity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance trainingBehavioural
45 min ergometer cycling at the ventilatory anaerobic threshold 4 times per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | 12 weeks of endurance training on the cycle ergometer under supervision on a physician Receives: Behavioral: Endurance training |
| Control | No intervention | Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical capacity
Secondary outcomes (2)
Left ventricular function
occurence of complications
Measured: within study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Collaborators
- The German Heart Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934609
- Sponsor's protocol ID
- 2000-01SaarlandU
- Acronym
- CHF
- Status last verified
- Sep 2009
- First submitted
- 7 Jul 2009
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12-weeks Endurance Training in Patients With Chronic Heart Failure Due to Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT00934609
- Acronym / sponsor ID
- CHF / 2000-01SaarlandU
- Conditions
- Dilated Cardiomyopathy, Chronic Heart Failure
- Keywords
- Exercise, heart failure, dilated cardiomyopathy, Endurance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Collaborators
- The German Heart Foundation
- First posted
- 8 Jul 2009 (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.
The study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Endurance training12 weeks of endurance training on the cycle ergometer under supervision on a physician |
| Control | No intervention | –Control condition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic heart failure NYHA stage 2 and 3
Key exclusion criteria (3 listed)
- Valvular disease
- recent decompensation
- Other complaints that might interfere with ergometer exercise
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 |
|---|---|---|
| Endurance training45 min ergometer cycling at the ventilatory anaerobic threshold 4 times per week for 12 weeks | Behavioural | Training |
Primary outcome
Physical capacity
2 secondary outcomes
Left ventricular function
occurence of complications
Time frame: within study period
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 18 Sep 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance training in people with Dilated Cardiomyopathy and Chronic Heart Failure, run by Universität des Saarlandes 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 1 inclusion and 3 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 18 Sep 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.
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?
Physical capacity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2009.