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NCT00865124 · ClinicalTrials.gov registry record · NA
Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 69
- Enrollment target
NCT00865124: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT00865124 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 69 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00865124, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 69 participants
- Enrollment target
Study Summary
Aldosterone is a significant mediator of cardiovascular injury associated with heart failure and the cardiovascular benefits of mineralocorticoid receptor blockade are additive to those of angiotensin converting enzyme inhibitors or angiotensin II (ANGII) receptor blockers. This study will test the hypothesis that mineralocorticoid receptor (MR) antagonists exert beneficial cardiovascular effects, specifically by decreasing vascular injury and improving vascular function. A randomized, double-blind study will be conducted, in which participants with Type 2 Diabetes Mellitus will undergo a series of assessments to test heart, blood vessel, and kidney function at baseline, and after 2 and 6 months of treatment with one of the following drugs: 1. spironolactone 2. hydrochlorothiazide (HCTZ) plus potassium 3. placebo In the event of insufficient funds, randomization to the placebo arm will be stopped and primary assessment of outcomes will occur at baseline and after 6 months of treatment.
Primary Outcome
Coronary flow reserve (CFR), or myocardial perfusion reserve, was assessed via cardiac positron emission tomography (PET). CFR is the ratio of adenosine-stimulated blood flow through myocardium to resting blood flow through myocardium. An improvement in coronary flow reserve is beneficial.
Interventions
- OTHER Placebo
- DRUG Spironolactone
- DRUG Hydrochlorothiazide + potassium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2008-09 |
| Est. Completion | 2014-05 |
| Phase | NA |
What the finished NCT00865124 record still lists
NCT00865124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00865124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00865124 about?
NCT00865124 is a clinical study titled "Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease". Aldosterone is a significant mediator of cardiovascular injury associated with heart failure and the cardiovascular benefits of mineralocorticoid receptor blockade are additive to those of angiotensin converting enzyme inhibitors or angiotensin II (ANGII) receptor blockers. This study will test the ...
What is the current status of trial NCT00865124?
This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2008-09. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00865124?
The interventions under investigation include: Placebo (OTHER), Spironolactone (DRUG), Hydrochlorothiazide + potassium (DRUG).
Who is sponsoring clinical trial NCT00865124?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00865124's enrollment target sits among peer trials
69 1133rd of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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