Mitral Valve Reconstruction in Chronic Heart Failure (CHF): Identification of Predictors for a Successful Therapy

• Sponsor: University of Leipzig (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00348829
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 75
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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. Collection of clinical factors for the assessment of the postoperative course after mitral valve reconstruction in CHF patient.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure; Mitral Insufficiency	Procedure: mitral valve repair	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Mitral Valve Reconstruction in Patients With Chronic Heart Failure and Secondary Mitral Insufficiency: Identification of Predictors for a Successful Therapy
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Surgical mitral valve reconstruction	Procedure: mitral valve repair; surgical mitral valve repair
No Intervention: 2 conservative treatment

Outcome Measures

Primary Outcome Measures

1. Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure [3 months]

Secondary Outcome Measures

1. Identification of clinical factors for the postoperative outcome [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age > 18 years old

2. Dilatative Cardiomyopathy with LVEF < 35%

3. NYHA III oder IV under maximal medical treatment

4. Angiographic and hemodynamic MI > II° (LAP- mean pressure > 15-20 mmHg; LA v-wave-oder PCWP v-wave > 35 mmHg under exercise)

5. Echocardiographic MI > II°

6. At least 1 hospitalization for heart failure before OP

Exclusion Criteria:

1. Secondary Cardiomyopathy by vitium cordis

2. Planned secondary procedure like CABG, aortic valve surgery, surgery of the tricuspid valve etc

3. Inclusion in another trial

4. Euro-Score > 30%

5. Former valve operation or CABG

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center Leipzig GmbH, University Leipzig	Leipzig		Germany	04289

Sponsors and Collaborators

• University of Leipzig

Investigators

• Study Chair: Gerhard Schuler, Prof., Chair of the Dep. of Cardiology
• Principal Investigator: Sven Möbius-Winkler, MD, Consultant of the dep. of Cardiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sven Möbius-Winkler, PD Dr. med., University of Leipzig
• ClinicalTrials.gov Identifier: NCT00348829
• Other Study ID Numbers: SMW 01
• First Posted: Jul 6, 2006
• Last Update Posted: Oct 27, 2016
• Last Verified: May 1, 2009

• Keywords provided by Sven Möbius-Winkler, PD Dr. med., University of Leipzig: CHF; mitral insufficiency; conductance catheter; mitral valve repair
• Additional relevant MeSH terms: Heart Failure; Mitral Valve Insufficiency

Study Results

No Results Posted as of Oct 27, 2016