Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187889
Status:
COMPLETED
Last Update Posted:
2013-10-14
First Post:
2005-09-10
Brief Title:
EWISE Study of Eplerenone in Women With Chest Pain Coronary Vascular Dysfunction and Evidence of Myocardial Ischemia
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
INDICATION Coronary Vascular Dysfunction Endothelial Dysfunction andor 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 PARAMETERS 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
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 PARAMETERS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01 H267173-01 | None | None | None |