search
Back to results

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

Primary Purpose

Chronic Heart Failure, Mitral Insufficiency

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
mitral valve repair
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Heart Failure focused on measuring CHF, mitral insufficiency, conductance catheter, mitral valve repair

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Heart Center Leipzig GmbH, University Leipzig

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

Surgical mitral valve reconstruction

conservative treatment

Outcomes

Primary Outcome Measures

Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure

Secondary Outcome Measures

Identification of clinical factors for the postoperative outcome

Full Information

First Posted
July 5, 2006
Last Updated
October 25, 2016
Sponsor
University of Leipzig
search

1. Study Identification

Unique Protocol Identification Number
NCT00348829
Brief Title
Mitral Valve Reconstruction in Chronic Heart Failure (CHF): Identification of Predictors for a Successful Therapy
Official Title
Mitral Valve Reconstruction in Patients With Chronic Heart Failure and Secondary Mitral Insufficiency: Identification of Predictors for a Successful Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Terminated
Why Stopped
not enough patients to e recruited, problems with the conductance catheter
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Mitral Insufficiency
Keywords
CHF, mitral insufficiency, conductance catheter, mitral valve repair

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Surgical mitral valve reconstruction
Arm Title
2
Arm Type
No Intervention
Arm Description
conservative treatment
Intervention Type
Procedure
Intervention Name(s)
mitral valve repair
Intervention Description
surgical mitral valve repair
Primary Outcome Measure Information:
Title
Identification of hemodynamic parameters as predictor for a successful mitral valve reconstruction in patients with congestive heart failure
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Identification of clinical factors for the postoperative outcome
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Schuler, Prof.
Organizational Affiliation
Chair of the Dep. of Cardiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sven Möbius-Winkler, MD
Organizational Affiliation
Consultant of the dep. of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Leipzig GmbH, University Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs