At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease
In Brief
A clinical study evaluating Spironolactone, Hydrochlorothiazide + potassium, and 1 other intervention for Type 2 Diabetes Mellitus and Vascular Disease. Completed, enrolled 69 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
25 mg capsule daily for 6 months
hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 milliequivalents (mEq) capsule daily
Placebo capsule daily