At a glance
ClinicalIndex Comparison Record- ✓Non-pregnant women aged 21-75 years with chest discomfort.
- ✓Suspected ischemic heart disease with no severe coronary stenosis (>50% diameter reduction) on coronary angiography.
- ✓Endothelial dysfunction defined as failure to dilate to intracoronary acetylcholine (<5% increase in mean lumen diameter).
- ✓Ideally on stable, maximally tolerated dose of ACE inhibitor or ARB.
- ✕Acute MI or unstable angina within 1 month of entry.
- ✕Uncontrolled moderate hypertension: sitting blood pressure >160/95 mmHg on at least 2 occasions.
- ✕Severe heart failure (NYHA Class III or IV).
- ✕Prior coronary revascularization (CABG, PTCA, or stent placement).
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Multicenter, Placebo Controlled Study of Aldosterone Blockade (Eplerenone) in Women With Chest Pain, Coronary Vascular Dysfunction and Evidence of Myocardial Ischemia in the Absence of Significant Epicardial Coronary Artery Disease
In Brief
A Phase 4 clinical trial evaluating Eplerenone and Placebo or sugar pill for Ischemic Heart Disease. Completed, enrolled 70 participants across 1 site.
Detailed Summary
Some women have chest pain even without having a blockage in one of the major blood vessels that supplies blood to the heart. In many of these women the microscopic (small) blood vessels in the heart do not function normally. This study seeks to determine if treatment with eplerenone, a commercially available diuretic, can improve the function of these microscopic blood vessels and, possibly, improve the chest pain.
Study Details
Timeline
Interventions
Eplerenone 25 mg (1 pill) daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.
Placebo blinded as 25 mg tablet(1 pill) once daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.