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Sponsors and Collaborators: |
University of Florida National Heart, Lung, and Blood Institute (NHLBI) Pfizer |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00187889 |
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.
Condition | Intervention | Phase |
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Ischemic Heart Disease |
Drug: eplerenone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2007 |
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 comparing the eplerenone group to the placebo group.
SECONDARY EFFICACY PARAMETERS: Microvascular coronary endothelial function at Week 16 comparing the eplerenone group to the placebo group.
OTHER EFFICACY PARAMETERS:
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.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carl J Pepine, MD | 3528460620 | pepincj@medicine.ufl.edu |
Contact: Eileen M Handberg, PhD | 3528460620 | handbem@medicine.ufl.edu |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32653 | |
Contact: Carl J Pepine, MD 352-846-0620 pepincj@medicine.ufl.edu | |
Contact: Eileen M Handberg, PhD 3528460620 handbem@medicine.ufl.edu | |
Principal Investigator: Carl J Pepine, MD |
Principal Investigator: | Carl J Pepine, MD | University of Florida |
Study ID Numbers: | EWISE, R01 H267173-01 |
Study First Received: | September 10, 2005 |
Last Updated: | September 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00187889 |
Health Authority: | United States: Institutional Review Board |
Microvascular Disease Women Ischemic Heart Disease WISE |
Coronary Disease Eplerenone Heart Diseases Myocardial Ischemia Vascular Diseases |
Pain Ischemia Coronary Artery Disease Chest Pain |
Aldosterone Antagonists Hormone Antagonists Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Diseases Pharmacologic Actions |