Phase 4
N=51
EWISE: Study of Eplerenone in Women With Chest Pain, Coronary Vascular Dysfunction and Evidence of Myocardial Ischemia
Ischemic Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00187889 ↗Enrolled (actual)
51
Serious AEs
2.0%
Results posted
Oct 2013
Primary outcome: Primary: Epicardial Coronary Artery Endothelial Function (Adjusted) at Week 16 Comparing the Eplerenone Group to the Placebo Group — -1.2; -10.7 % change wk16-%change wk0- unitless — p=0.15
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Eplerenone (Drug); Placebo or sugar pill (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of Florida
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Epicardial Coronary Artery Endothelial Function (Adjusted) at Week 16 Comparing the Eplerenone Group to the Placebo Group |
-1.2; -10.7 | 0.15 |
| SECONDARY Microvascular Coronary Flow Reserve(Adjusted) at Week 16 Adjusted for Baseline Coronary Flow Reserve Comparing the Eplerenone Group to the Placebo Group |
-0.4; -0.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Non-pregnant women with chest discomfort who are 21 to 75 years of age and from diverse racial/ethnic groups.
- Suspected ischemic heart disease (IHD) but no severe coronary stenosis (> 50% diameter reduction) on coronary angiography used to qualify for WISE.
- Endothelial dysfunction, defined as failure to dilate to intracoronary acetylcholine ( 160/95mmHg with measurements recorded on at least 2 occasions (for blood pressure control patients must first be stabilized, preferably with a diuretic, and remain on that dosing regimen throughout participation in the study).
- Severe heart failure defined as New York Heart Association (NYHA) Class III or IV on treatment.
- Coronary revascularization by either coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) or stent placement.
- Conditions likely to influence outcomes independent of IHD: severe lung, renal (creatinine >1.8 or creatinine clearance [CrCl] ≤ 50ml/min) or hepatic disease; surgically uncorrected significant congenital or valvular heart disease; and other diseases likely to be fatal or require frequent hospitalizations within the next six months.
- Adherence or retention reasons: recent alcoholism or drug abuse; psychiatric illness including severe depression; dementia; active participation in any other research trial other than WISE; or unwilling to complete follow-up evaluations including repeat testing.
- Hypersensitivity to any medications to be used in the study
- Documented obstructive hypertrophic cardiomyopathy.
- Aortic stenosis (valve area 5.0meq/l at baseline
- Taking potent CYP3A4 inhibitors (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir)
- Intolerance to ACEI and ARB medications
- Use of potassium supplements or potassium sparing diuretics
Data sourced from ClinicalTrials.gov (NCT00187889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.