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

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Eplerenone
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
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  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2004
Last Updated
December 19, 2020
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00082589
Brief Title
The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure
Acronym
REMODEL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Eplerenone
Primary Outcome Measure Information:
Title
Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8411
Country
United States
Facility Name
Pfizer Investigational Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Pfizer Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598-3084
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309-1721
Country
United States
Facility Name
Pfizer Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Pfizer Investigational Site
City
Covington
State/Province
Georgia
ZIP/Postal Code
30014
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704-0107
Country
United States
Facility Name
Pfizer Investigational Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Pfizer Investigational Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Pfizer Investigational Site
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Nebraska
ZIP/Postal Code
68850
Country
United States
Facility Name
Pfizer Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Pfizer Investigational Site
City
McCook
State/Province
Nebraska
ZIP/Postal Code
69001
Country
United States
Facility Name
Pfizer Investigational Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Pfizer Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Pfizer Investigational Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Pfizer Investigational Site
City
West Islip
State/Province
New York
ZIP/Postal Code
11795
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27109
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Pfizer Investigational Site
City
Lorain
State/Province
Ohio
ZIP/Postal Code
44053
Country
United States
Facility Name
Pfizer Investigational Site
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870-3390
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Pfizer Investigational Site
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Pfizer Investigational Site
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Pfizer Investigational Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Pfizer Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77630
Country
United States
Facility Name
Pfizer Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Galax
State/Province
Virginia
ZIP/Postal Code
24333
Country
United States
Facility Name
Pfizer Investigational Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Pfizer Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20299607
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6141078&StudyName=The+Purpose+of+this+Study+is+to+Determine+if+Eplerenone+is+Effective+in+Treatment+of+Mild+to+Moderate+Heart+Failure
Description
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Learn more about this trial

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

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