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NCT00587470 · ClinicalTrials.gov registry record · Phase 4

Angiotensin-II Blockade in Mitral Regurgitation

A Phase 4 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 4
Development phase
60
Enrollment target

NCT00587470: Completed Phase 4 study, sponsored by Mayo Clinic.

NCT00587470 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00587470, a Phase 4 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 4
Development phase
60 participants
Enrollment target

Study Summary

Mitral regurgitation (MR) is common in the elderly and its prevalence is increasing with the aging of the population. Organic MR, due to primary valvular lesions, initiates a cascade of complications determined by its degree. MR of severe degree is associated with excess mortality and high cardiac morbidity (heart failure, atrial fibrillation). It also causes left ventricular remodeling which induces left ventricular dysfunction, which in turn leads to poor clinical outcome. Surgery can eliminate MR, but carries immediate and long-term risks, especially in the elderly. Therefore, chronically decreasing the degree of MR is a major goal of medical therapy but such an effect is yet unproved because of conflicting results of small and mostly non-randomized series. Our recent preliminary studies suggest that a sustained decrease of degree of MR and improvement of left ventricular remodeling can be achieved with powerful reduction of afterload, obtained in particular with angiotensin-II receptor blockade. Therefore, the present proposal seeks to address gaps of knowledge regarding vasoactive treatment of MR through the verification of the following hypothesis: Hypothesis: Vasoactive therapy using angiotensin-II receptor blocker (Candesartan Cilexetil) weighed against placebo produces a sustained reduction of the consequences of organic MR. The specific aims are that the treatment a) decreases the degree of MR (decreases the regurgitant volume, primary end-point) and b) improves left ventricular remodeling (decreases the end-diastolic volume index, secondary end-point), as compared to placebo.

Interventions

  • DRUG Placebo
  • DRUG Candesartan
  • DRUG atacand

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 1998-08
Est. Completion 2001-08
Phase Phase 4
Mayo Clinic

2,844 total trials

What the finished NCT00587470 record still lists

NCT00587470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00587470 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00587470 about?

NCT00587470 is a clinical study titled "Angiotensin-II Blockade in Mitral Regurgitation". Mitral regurgitation (MR) is common in the elderly and its prevalence is increasing with the aging of the population. Organic MR, due to primary valvular lesions, initiates a cascade of complications determined by its degree. MR of severe degree is associated with excess mortality and high cardiac m...

What is the current status of trial NCT00587470?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 1998-08. Estimated completion is 2001-08.

What interventions are being tested in trial NCT00587470?

The interventions under investigation include: Placebo (DRUG), Candesartan (DRUG), atacand (DRUG).

Who is sponsoring clinical trial NCT00587470?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00587470's enrollment target sits among peer trials

60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT00587470, the US trial registry maintained by the National Library of Medicine. NCT00587470 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.