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Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure

NCT00608140 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-04-04

Study results available
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Summary

Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the heart. Improper functioning of the mitral valve disrupts the proper flow of blood through the body, resulting in shortness of breath and fatigue. When mild, MR may not pose a significant danger to a person's health, but severe MR may be associated with serious complications, such as heart failure, irregular heart rhythm, and high blood pressure. Although there are treatments for MR, including medication and surgery, more information is needed on the effectiveness of these treatments in people with significant MR. This study will compare the safety and effectiveness of corrective surgery added to optimal medical treatment (OMT) versus OMT alone in treating people with significant MR caused by an enlarged heart.

Conditions

Interventions

PROCEDURE

Surgical mitral valvuloplasty with placement of annular ring (SMVR)

Participants will undergo open heart surgery to mechanically reduce mitral regurgitation (MR). A complete rigid or semi-rigid annular ring will be placed unless specifically contraindicated by intraoperative findings. The ring size will be between 24 mm and 27 mm in the anteroposterior diameter. Annular ring sutures will be placed circumferentially approximately 1 mm off the hinge point between the leaflet and the atrial tissue. The total number of sutures will vary between 4 and 7 sutures anteriorly, while 8 to 12 sutures will be utilized for the posterior segment of the annulus. Additional repair of the mitral apparatus itself will be based on intraoperative findings. Leaflet repair will be performed for significant prolapse. Submitral apparatus repair will be performed for ruptured or significantly elongated chordae as well as significant chordal tethering.

DRUG

Optimal medical therapy (OMT)

Optimal medical therapy can include, but is not limited to, any of the following treatment regimens: combination of vasodilator therapy and diuretics, nitrates and nifedipine, and beta-adrenergic blocker therapy.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Heart Failure Clinical Research Network

    collaborator UNKNOWN

  • Duke University

    lead OTHER

Principal Investigators

  • Kerry L. Lee, PhD · Duke Clinical Research Institute

  • Eugene Braunwald, MD · Harvard University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00608140 on ClinicalTrials.gov