ABOUT THIS STUDY
- 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 (< 5% increase in mean lumen diameter).
- If possible, patients should be taking stable, maximally tolerated dose of either an angiotensin-converting enzyme inhibitor [ACEI] (or an angiotensin II receptor blocker [ARB] if ACEI intolerant)
- Women who are breast-feeding or who are pregnant. Women of childbearing potential may
be enrolled but must agree not to become pregnant during the course of the study and
must practice a method of birth control considered reliable by the investigator. If
established on hormonal contraceptives for more than 3 months, patients will be
allowed to participate provided that this therapy remains constant throughout the
study. If a patient becomes pregnant or begins breast-feeding during the study, she
must be withdrawn immediately.
- Acute ischemic syndrome defined as acute myocardial infarction [MI] (by enzyme or
electrocardiogram [ECG] criteria) or unstable angina within 1 month of entry.
- Uncontrolled moderate hypertension: sitting blood pressure > 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
- 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
- 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
- Hypersensitivity to any medications to be used in the study
- Documented obstructive hypertrophic cardiomyopathy.
- Aortic stenosis (valve area < 1.5cm).
- Left ventricular (LV) dysfunction (ejection fraction <= 35%).
- History of significant cocaine or amphetamine abuse.
- Serum potassium > 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
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Gainesville, Florida