The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure (REMODEL)

Viatris

Status and phase: Completed; Phase 4

Conditions: Heart Failure, Congestive

Treatments: Drug: Eplerenone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00082589

A6141078

Details and patient eligibility

About

The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind