Ischemic Heart Disease Clinical Trial
Official title:
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
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.
INDICATION: Coronary Vascular Dysfunction (Endothelial Dysfunction and/or Microvascular
angina).
OBJECTIVES: To investigate effects of aldosterone blockade (eplerenone) on coronary vascular
function.
PATIENT POPULATION: Women who meet the National Heart, Lung and Blood Institute-sponsored
WISE (Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary
vascular dysfunction and undergoing evaluation for myocardial ischemia in the absence of
significant coronary artery stenosis.
STUDY DESIGN: A prospective, randomized, double blind placebo-controlled, comparative trial
of eplerenone, given in the presence of a renin-angiotensin blocker (ACE-I or ARB in the case
of ACE-I intolerance).
TREATMENT: Eplerenone 25mg titrated to 50mg as tolerated per day versus placebo for four
months
PRIMARY EFFICACY PARAMETER(S): Epicardial coronary artery endothelial function at Week 16
(adjusted for baseline treatment group and site by treatment interaction variables) comparing
the eplerenone group to the placebo group.
SECONDARY EFFICACY PARAMETERS: Microvascular coronary endothelial function at Week 16
(adjusted for baseline treatment group and site by treatment interaction variables) comparing
the eplerenone group to the placebo group.
OTHER EFFICACY PARAMETERS:
- Coronary flow reserve
- Chest discomfort as measured by the Seattle Angina Questionnaire
- DASI
SAFETY PARAMETERS: Blood pressure, pulse rate and frequency and occurrence of adverse events.
The latter will include serum K and Creatinine.
STATISTICAL RATIONALE AND ANALYSIS: A statistical rationale for the number of patients in the
study has been provided. Interim analyses are planned after 10 patients have completed
treatment in each group.
ANTICIPATED TOTAL NUMBER OF PATIENTS: 50 (25 per treatment group).
ANTICIPATED NUMBER OF PATIENTS AT EACH SITE: Approximately 13.
PARTICIPATING SITES: University of Florida (Carl Pepine, MD), Emory University (Arshed
Quyyumi, MD), Rhode Island Hospital (Barry Sharaf, MD), and Mayo Clinic (Amir Lerman, MD).
There is an existing relationship between the first 3 sites and the Mayo Clinic site is
familiar with all necessary protocol procedures and is anxious to participate. The University
of Florida will serve as the main contracting site.
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