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

October 25, 2016 updated by: Sven Möbius-Winkler, University of Leipzig

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.

  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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • Heart Center Leipzig GmbH, University Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Surgical mitral valve reconstruction
Procedure: mitral valve repair
surgical mitral valve repair
NO_INTERVENTION: 2
conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Identification of clinical factors for the postoperative outcome
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

July 5, 2006

First Submitted That Met QC Criteria

July 5, 2006

First Posted (ESTIMATE)

July 6, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMW 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe