Chronic Heart FailureNCT02046707
Evaluation of the Effects of Eccentric Muscle Training Versus Conventional Concentric Training in Chronic Heart Failure
A study testing initial evaluation, Period of cardiac rehabilitation and final evaluation in people with Chronic Heart Failure and Reconditioning to Effort, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This is a single-centre open randomized parallel-group study. Patients will be selected at random to be included in group 1: eccentric rehabilitation or group 2: conventional rehabilitation. In addition, a group of healthy volunteers aged between 20 and 85 years will also be recruited. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Chronic Heart Failure, Reconditioning to Effort
- What is being tested?
- initial evaluation, Period of cardiac rehabilitation and final evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2014to 23 Mar 2015
- 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 45 to 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients :
- Patients who have provided written informed consent
- Patients with national health insurance cover
- Men or women aged between 45 and 85 years with stabilized chronic heart failure (ischemic or dilated cardiopathy) for at least one month, New York Heart Association stage> 2.
- Echocardiographic left ventricular ejection fraction (Simpson method) < 45% OR N-terminal-ProBNP > 3 x upper limit of normal* (*= 125pg/ml for the CHU laboratory).
- First period of rehabilitation for chronic heart failure.
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- Healthy volunteers:
- Subjects who have provided written informed consent
- Subjects with national health insurance cover
- Men or women aged between 18 and 85 years.
Who cannot join
- Patients:
- persons without national health insurance cover
- Severe obstructive cardiopathy,
- severe aortic valve stenosis,
- severe progressive heart rhythm or conduction disorders not corrected with a pacemaker, discovered at the initial effort test
- intra-cavitary thrombus,
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- severe pulmonary artery hypertension (systolic pulmonary arterial hypertension >70mmHg),
- recent history of venous trombo-embolism (last 3 months),
- impaired executive function making it impossible to understand and follow reconditioning programme (Mini Mental Test < 24),
- heart transplant,
- associated medical disorders that could predominately impair functional capacity compared with the chronic heart failure (examples: respiratory insufficiency, non-stabilized metabolic disorders such as progressive kidney failure, severe asthenia related to a severe non-stabilized disorder such as neoplasia, systemic disease…).
- associated chronic motor deficit of a neurological origin (example: sequelae of a cerebrovascular accident), an osteo-articular origin (example: impairment due to Rheumatoid arthritis), of a peripheral vascular disease (example: peripheral artery disease, venous disease, lymphedema) will not be included in the exclusion criteria provided thay are compatible with the level of physical ability defined in the inclusion criteria. The presence of an implantable pacemaker and/or defibrillator will not be an exclusion criterion
- Healthy volunteers:
- persons without national health insurance cover
- Any organic disorder whatever its nature (cardiac, respiratory, neurological, orthopedic, …) that could affect adaptation to effort or is a contra-indication for physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-centre open randomized parallel-group study. Patients will be selected at random to be included in group 1: eccentric rehabilitation or group 2: conventional rehabilitation.
In addition, a group of healthy volunteers aged between 20 and 85 years will also be recruited. This group will make it possible to evaluate, during the two exercise sessions, mechanisms of adaptation linked to eccentric exercise vs concentric exercise.
- Conditions
- Chronic Heart Failure, Reconditioning to Effort
- Being tested
- initial evaluation, Period of cardiac rehabilitation, final evaluation, Concentric and eccentric exercise sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
initial evaluationOther
Period of cardiac rehabilitationOther
final evaluationOther
Concentric and eccentric exercise sessionsOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic heart failure | Experimental | Not described Receives: Other: initial evaluation; Other: Period of cardiac rehabilitation; Other: final evaluation |
| Controls | Other | Not described Receives: Other: Concentric and eccentric exercise sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of performance in the 6-minute walk test between the initial assessment and the final assessment of a reconditioning programme
Measured: 12 weeks
Secondary outcomes (1)
Evolution of functional and physiological capacities and tolerance criteria
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study start29 Aug 2014
- Primary completion23 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046707
- Sponsor's protocol ID
- CASILLAS Fondation Av 2008
- Status last verified
- May 2019
- First submitted
- 20 Jan 2014
- Last updated
- 7 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Eccentric Muscle Training Versus Conventional Concentric Training in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02046707
- Acronym / sponsor ID
- CASILLAS Fondation Av 2008
- Conditions
- Chronic Heart Failure, Reconditioning to Effort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Aug 2014 (actual)
- Primary completion
- 23 Mar 2015 (actual)
- First posted
- 28 Jan 2014 (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.
This is a single-centre open randomized parallel-group study. Patients will be selected at random to be included in group 1: eccentric rehabilitation or group 2: conventional rehabilitation.
In addition, a group of healthy volunteers aged between 20 and 85 years will also be recruited. This group will make it possible to evaluate, during the two exercise sessions, mechanisms of adaptation linked to eccentric exercise vs concentric exercise.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic heart failure | Experimental | Other: initial evaluation, Other: Period of cardiac rehabilitation, Other: final evaluation |
| Controls | Other | Other: Concentric and eccentric exercise sessions |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who have provided written informed consent
- Patients with national health insurance cover
- Men or women aged between 45 and 85 years with stabilized chronic heart failure (ischemic or dilated cardiopathy) for at least one month, New York Heart Association stage> 2.
- Echocardiographic left ventricular ejection fraction (Simpson method) < 45% OR N-terminal-ProBNP > 3 x upper limit of normal* (*= 125pg/ml for the CHU laboratory).
- First period of rehabilitation for chronic heart failure.
Key exclusion criteria (15 listed)
- persons without national health insurance cover
- Severe obstructive cardiopathy,
- severe aortic valve stenosis,
- severe progressive heart rhythm or conduction disorders not corrected with a pacemaker, discovered at the initial effort test
- intra-cavitary thrombus,
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 |
|---|---|---|
| initial evaluation | Other | Patients with chronic heart failure |
| Period of cardiac rehabilitation | Other | Patients with chronic heart failure |
| final evaluation | Other | Patients with chronic heart failure |
| Concentric and eccentric exercise sessions | Other | Controls |
Primary outcome
Evolution of performance in the 6-minute walk test between the initial assessment and the final assessment of a reconditioning programme
Time frame: 12 weeks
1 secondary outcome
Evolution of functional and physiological capacities and tolerance criteria
Time frame: 12 weeks
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 7 May 2019.
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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 initial evaluation, Period of cardiac rehabilitation and final evaluation in people with Chronic Heart Failure and Reconditioning to Effort, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 10 inclusion and 15 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 7 May 2019. 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 France. 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?
Evolution of performance in the 6-minute walk test between the initial assessment and the final assessment of a reconditioning programme (time frame: 12 weeks). 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 7 May 2019.