The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure
Phase 4
Completed
- Conditions
- Heart Failure, Congestive
- Registration Number
- NCT00082589
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
- Current symptoms consistent with mild to moderate heart failure (NYHA functional class II and III)
- LVEF (left ventricular ejection fraction) of <35% by equilibrium-gated RVG at screening
- Therapy with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) and beta-blocker (BB) (unless documented intolerance) for at least 3 months duration and at dose that has not been adjusted within the previous 4 weeks
Exclusion Criteria
- Current decompensated heart failure or heart failure hospitalization or severe heart failure (NYHA functional class IV) within 6 months of screening
- Use of eplerenone or spironolactone within 30 days of randomization or for more than 7 days within the previous 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Madison, Wisconsin, United States