Chronic Heart FailurePhase 2NCT00348829
Mitral Valve Reconstruction in Chronic Heart Failure (CHF): Identification of Predictors for a Successful Therapy
A Phase 2 study testing mitral valve repair in people with Chronic Heart Failure and Mitral Insufficiency, run by University of Leipzig at 1 site in Germany.
Trial summary
The aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients with secondary mitral insufficiency and CHF. 1. Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in CHF patients. 2. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Heart Failure, Mitral Insufficiency
- What is being tested?
- mitral valve repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Sep 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Dilatative Cardiomyopathy with LVEF < 35%
- NYHA III oder IV under maximal medical treatment
- Angiographic and hemodynamic MI > II° (LAP- mean pressure > 15-20 mmHg; LA v-wave-oder PCWP v-wave > 35 mmHg under exercise)
- Echocardiographic MI > II°
- At least 1 hospitalization for heart failure before OP
Who cannot join
- Secondary Cardiomyopathy by vitium cordis
- Planned secondary procedure like CABG, aortic valve surgery, surgery of the tricuspid valve etc
- Inclusion in another trial
- Euro-Score > 30%
- Former valve operation or CABG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitral Valve Reconstruction in Patients With Chronic Heart Failure and Secondary Mitral Insufficiency: Identification of Predictors for a Successful Therapy
The aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients with secondary mitral insufficiency and CHF.
- Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in CHF patients.
- Collection of clinical factors for the assessment of the postoperative course after mitral valve reconstruction in CHF patient.
- Conditions
- Chronic Heart Failure, Mitral Insufficiency
- Being tested
- mitral valve repair
- Keywords
- CHF, mitral insufficiency, conductance catheter, mitral valve repair
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve repairProcedure or surgery
surgical mitral valve repair
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Surgical mitral valve reconstruction Receives: Procedure: mitral valve repair |
| 2 | No intervention | conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure
Measured: 3 months
Secondary outcomes (1)
Identification of clinical factors for the postoperative outcome
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 posted6 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2008
- Study completionSep 2012
Why it stopped: not enough patients to e recruited, problems with the conductance catheter
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.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Möbius-Winkler, University of Leipzig
- Investigators
- Gerhard Schuler, Prof., Study chair, Chair of the Dep. of CardiologySven Möbius-Winkler, MD, Principal investigator, Consultant of the dep. of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348829
- Sponsor's protocol ID
- SMW 01
- Status last verified
- May 2009
- First submitted
- 5 Jul 2006
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitral Valve Reconstruction in Patients With Chronic Heart Failure and Secondary Mitral Insufficiency: Identification of Predictors for a Successful Therapy
- ClinicalTrials.gov ID
- NCT00348829
- Acronym / sponsor ID
- SMW 01
- Conditions
- Chronic Heart Failure, Mitral Insufficiency
- Keywords
- CHF, mitral insufficiency, conductance catheter, mitral valve repair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients to e recruited, problems with the conductance catheter
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Jul 2006 (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 aim of the study is to evaluate hemodynamic and echocardiographic parameters in patients with secondary mitral insufficiency and CHF.
- Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in CHF patients.
- Collection of clinical factors for the assessment of the postoperative course after mitral valve reconstruction in CHF patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: mitral valve repairSurgical mitral valve reconstruction |
| 2 | No intervention | –conservative treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years old
- Dilatative Cardiomyopathy with LVEF < 35%
- NYHA III oder IV under maximal medical treatment
- Angiographic and hemodynamic MI > II° (LAP- mean pressure > 15-20 mmHg; LA v-wave-oder PCWP v-wave > 35 mmHg under exercise)
- Echocardiographic MI > II°
Key exclusion criteria (5 listed)
- Secondary Cardiomyopathy by vitium cordis
- Planned secondary procedure like CABG, aortic valve surgery, surgery of the tricuspid valve etc
- Inclusion in another trial
- Euro-Score > 30%
- Former valve operation or CABG
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 |
|---|---|---|
| mitral valve repairsurgical mitral valve repair | Procedure or surgery | 1 |
Primary outcome
Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure
Time frame: 3 months
1 secondary outcome
Identification of clinical factors for the postoperative outcome
Time frame: 3 months
Results and safety
The study was stopped early (reason given: not enough patients to e recruited, problems with the conductance catheter). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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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.
Gerhard Schuler, Prof. study chair
Chair of the Dep. of Cardiology
Sven Möbius-Winkler, MD principal investigator
Consultant of the dep. of 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 mitral valve repair in people with Chronic Heart Failure and Mitral Insufficiency, 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 5 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: stopped early, as of the sponsor's last update on 27 Oct 2016. 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 was stopped early (reason given: not enough patients to e recruited, problems with the conductance catheter). Results are not available in the source record.
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?
Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure (time frame: 3 months). 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 27 Oct 2016.