Heart FailureNCT00472238
Effects of Endurance Training on Patients With Reduced Left Ventricular Ejection Fraction (LVEF) and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias
A study testing endurance training and exercise training in people with Heart Failure and Cardiac Resynchronisation Therapy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
A severely reduced left ventricular ejection fraction is associated with increased mortality due to pump failure as well as to malignant ventricular arrhythmia. We hypothesize that targeted training may lead to improved survival and to increased parameters of risk stratification for malignant arrhythmia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Cardiac Resynchronisation Therapy, Sudden Cardiac Death
- What is being tested?
- endurance training and exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to Dec 2008
- 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
- CRT Device
Who cannot join
- refused informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité campus Benjamin Franklin
Berlin, State of Berlin, 12200
Dirk Müller, MD, PhD, +49 39 8445 ext. 3554, dr.dirk.mueller@charite.de
Fernando C Dimeo, MD, PhD, +49 30 8445 ext. 2098, fernando.dimeo@charite.de
About this study
Official title: Effects of Endurance Training on Patients With Reduced LVEF and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias
A severely reduced left ventricular ejection fraction is associated with increased mortality due to pump failure as well as to malignant ventricular arrhythmia. We hypothesize that targeted training may lead to improved survival and to increased parameters of risk stratification for malignant arrhythmia. Additionally, the training may lead to an improved psychological and mental condition of the patients
- Being tested
- endurance training, exercise training
- Medical subject headings
- Heart Failure, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endurance trainingBehavioural
control group.
exercise trainingBehavioural
Treadmill exercise training to optimize physical endurance
| Study group | Role | What they receive |
|---|---|---|
| 1, Training | Experimental | Group for training therapy Receives: Behavioral: exercise training |
| 2, Control | Active comparator | Not described Receives: Behavioral: endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular function
Measured: 3 months
aerobic threshold
Measured: 3 months
Secondary outcomes (1)
quality of life
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startAug 2007
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Dirk Müller, MD, PhD, Principal investigator, Charite University, Berlin, GermanyFernando C Dimeo, MD, PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472238
- Sponsor's protocol ID
- CBF-2007001
- Other IDs
- 001
- Status last verified
- May 2007
- First submitted
- 10 May 2007
- Last updated
- 20 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Endurance Training on Patients With Reduced LVEF and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias
- ClinicalTrials.gov ID
- NCT00472238
- Acronym / sponsor ID
- CBF-2007001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Dec 2008 (estimated)
- First posted
- 11 May 2007 (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.
A severely reduced left ventricular ejection fraction is associated with increased mortality due to pump failure as well as to malignant ventricular arrhythmia. We hypothesize that targeted training may lead to improved survival and to increased parameters of risk stratification for malignant arrhythmia. Additionally, the training may lead to an improved psychological and mental condition of the patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, Training | Experimental | Behavioral: exercise trainingGroup for training therapy |
| 2, Control | Active comparator | Behavioral: endurance training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CRT Device
Key exclusion criteria (1 listed)
- refused informed consent
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 trainingcontrol group. | Behavioural | 2, Control |
| exercise trainingTreadmill exercise training to optimize physical endurance | Behavioural | 1, Training |
Primary outcome
left ventricular function
Time frame: 3 months
aerobic threshold
Time frame: 3 months
1 secondary outcome
quality of life
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2008.
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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.
Dirk Müller, MD, PhD principal investigator
Charite University, Berlin, Germany
Fernando C Dimeo, MD, PhD principal investigator
Charite University, Berlin, Germany
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 and exercise training in people with Heart Failure and Cardiac Resynchronisation Therapy, run by Charite University, Berlin, Germany 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 1 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: status not confirmed, as of the sponsor's last update on 20 Nov 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular function (time frame: 3 months). 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?
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 20 Nov 2008.