The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure
REMODEL
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
1 other identifier
interventional
250
1 country
53
Brief Summary
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2004
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 12, 2004
CompletedFirst Posted
Study publicly available on registry
May 14, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedDecember 22, 2020
December 1, 2020
May 12, 2004
December 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Pfizer Investigational Site
Castro Valley, California, 94546, United States
Pfizer Investigational Site
San Diego, California, 92103-8411, United States
Pfizer Investigational Site
Santa Rosa, California, 95403, United States
Pfizer Investigational Site
Walnut Creek, California, 94598-3084, United States
Pfizer Investigational Site
Denver, Colorado, 80262, United States
Pfizer Investigational Site
New Haven, Connecticut, 06510, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308, United States
Pfizer Investigational Site
Jacksonville, Florida, 32209, United States
Pfizer Investigational Site
Jacksonville, Florida, 32216, United States
Pfizer Investigational Site
Atlanta, Georgia, 30309-1721, United States
Pfizer Investigational Site
Augusta, Georgia, 30901, United States
Pfizer Investigational Site
Covington, Georgia, 30014, United States
Pfizer Investigational Site
Boise, Idaho, 83704-0107, United States
Pfizer Investigational Site
Bloomington, Illinois, 61701, United States
Pfizer Investigational Site
Normal, Illinois, 61761, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46202, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46260, United States
Pfizer Investigational Site
Auburn, Maine, 04210, United States
Pfizer Investigational Site
Ann Arbor, Michigan, 48105, United States
Pfizer Investigational Site
Detroit, Michigan, 48201, United States
Pfizer Investigational Site
Minneapolis, Minnesota, 55415, United States
Pfizer Investigational Site
Minneapolis, Minnesota, 55422, United States
Pfizer Investigational Site
St Louis, Missouri, 63104, United States
Pfizer Investigational Site
St Louis, Missouri, 63110-0250, United States
Pfizer Investigational Site
St Louis, Missouri, 63110, United States
Pfizer Investigational Site
St Louis, Missouri, 63117, United States
Pfizer Investigational Site
Lexington, Nebraska, 68850, United States
Pfizer Investigational Site
Lincoln, Nebraska, 68516, United States
Pfizer Investigational Site
McCook, Nebraska, 69001, United States
Pfizer Investigational Site
Lebanon, New Hampshire, 03756, United States
Pfizer Investigational Site
Albany, New York, 12205, United States
Pfizer Investigational Site
Manhasset, New York, 11030, United States
Pfizer Investigational Site
New York, New York, 10032, United States
Pfizer Investigational Site
West Islip, New York, 11795, United States
Pfizer Investigational Site
Mount Airy, North Carolina, 27030, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27109, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45219, United States
Pfizer Investigational Site
Lorain, Ohio, 44053, United States
Pfizer Investigational Site
Sandusky, Ohio, 44870-3390, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73120, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19107, United States
Pfizer Investigational Site
Sayre, Pennsylvania, 18840, United States
Pfizer Investigational Site
Pawtucket, Rhode Island, 02860, United States
Pfizer Investigational Site
Charleston, South Carolina, 29401, United States
Pfizer Investigational Site
Germantown, Tennessee, 38138, United States
Pfizer Investigational Site
Nashville, Tennessee, 37212, United States
Pfizer Investigational Site
Beaumont, Texas, 77630, United States
Pfizer Investigational Site
Beaumont, Texas, 77702, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Galax, Virginia, 24333, United States
Pfizer Investigational Site
Roanoke, Virginia, 24014, United States
Pfizer Investigational Site
Madison, Wisconsin, 53792, United States
Related Publications (1)
Udelson JE, Feldman AM, Greenberg B, Pitt B, Mukherjee R, Solomon HA, Konstam MA. Randomized, double-blind, multicenter, placebo-controlled study evaluating the effect of aldosterone antagonism with eplerenone on ventricular remodeling in patients with mild-to-moderate heart failure and left ventricular systolic dysfunction. Circ Heart Fail. 2010 May;3(3):347-53. doi: 10.1161/CIRCHEARTFAILURE.109.906909. Epub 2010 Mar 18.
PMID: 20299607DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2004
First Posted
May 14, 2004
Study Start
April 1, 2004
Study Completion
March 1, 2006
Last Updated
December 22, 2020
Record last verified: 2020-12