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

A Randomized, Double-Blind, Multi-Center,Study Evaluating the Effects of Eplerenone Versus Placebo on Ventricular Remodeling in Patient's With Left Ventricular Systolic Dysfunction (EF Less Than or Equal to 35%) and Mild to Moderate Heart Failure

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00082589

Acronym

REMODEL

Enrollment

250

Registered

2004-05-14

Start date

2004-04-30

Completion date

2006-03-31

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive

Brief summary

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

Interventions

DRUGEplerenone

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026