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

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-05-12
• Study First Submitted QC: 2004-05-13
• Study First Posted: 2004-05-14
• Study Completion: 2006-03
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-19
• Last Update Posted: 2020-12-22

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)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Madison, Wisconsin, United States