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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: Clinical Trial Phase 3 study, sponsored by Duke University.
NCT00608140 is a Phase 3 study that was terminated before completion, run by Duke University. The registered enrollment target is 2 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00608140 stopped before completion
NCT00608140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00608140's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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