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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 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 69 participants.

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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.

Interventions

  • OTHER Placebo
  • DRUG Spironolactone
  • DRUG Hydrochlorothiazide + potassium

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2008-09
Est. Completion 2014-05
Phase NA

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT00865124

The ClinicalTrials.gov registry entry for NCT00865124 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

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

NCT00865124 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.