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NCT00608140 · ClinicalTrials.gov registry record · Phase 3
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
A Phase 3 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2
- Enrollment target
NCT00608140 is a Phase 3 study that was terminated before completion, run by Duke University. The registered enrollment target is 2 participants.
The verdict
NCT00608140, a Phase 3 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Surgical mitral valvuloplasty with placement of annular ring (SMVR)
- DRUG Optimal medical therapy (OMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2008-03 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00608140
The ClinicalTrials.gov registry entry for NCT00608140 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Surgical mitral valvuloplasty with placement of annular ring (SMVR) is the first listed.
NCT00608140 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00608140 about?
NCT00608140 is a clinical study titled "Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure". 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 flo...
What is the current status of trial NCT00608140?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2 participants. The study started on 2008-03. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00608140?
The interventions under investigation include: Surgical mitral valvuloplasty with placement of annular ring (SMVR) (PROCEDURE), Optimal medical therapy (OMT) (DRUG).
Who is sponsoring clinical trial NCT00608140?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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