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

December 19, 2020 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Castro Valley, California, United States, 94546
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103-8411
        • Pfizer Investigational Site
      • Santa Rosa, California, United States, 95403
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94598-3084
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80262
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Pfizer Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32209
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309-1721
        • Pfizer Investigational Site
      • Augusta, Georgia, United States, 30901
        • Pfizer Investigational Site
      • Covington, Georgia, United States, 30014
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704-0107
        • Pfizer Investigational Site
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Pfizer Investigational Site
      • Normal, Illinois, United States, 61761
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • Pfizer Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Pfizer Investigational Site
      • Detroit, Michigan, United States, 48201
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, United States, 55422
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63104
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63117
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63110-0250
        • Pfizer Investigational Site
    • Nebraska
      • Lexington, Nebraska, United States, 68850
        • Pfizer Investigational Site
      • Lincoln, Nebraska, United States, 68516
        • Pfizer Investigational Site
      • McCook, Nebraska, United States, 69001
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12205
        • Pfizer Investigational Site
      • Manhasset, New York, United States, 11030
        • Pfizer Investigational Site
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
      • West Islip, New York, United States, 11795
        • Pfizer Investigational Site
    • North Carolina
      • Mount Airy, North Carolina, United States, 27030
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27109
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Lorain, Ohio, United States, 44053
        • Pfizer Investigational Site
      • Sandusky, Ohio, United States, 44870-3390
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Pfizer Investigational Site
      • Sayre, Pennsylvania, United States, 18840
        • Pfizer Investigational Site
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Pfizer Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37212
        • Pfizer Investigational Site
    • Texas
      • Beaumont, Texas, United States, 77702
        • Pfizer Investigational Site
      • Beaumont, Texas, United States, 77630
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
    • Virginia
      • Galax, Virginia, United States, 24333
        • Pfizer Investigational Site
      • Roanoke, Virginia, United States, 24014
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

May 12, 2004

First Submitted That Met QC Criteria

May 13, 2004

First Posted (Estimate)

May 14, 2004

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 19, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6141078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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