Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health (NIH)