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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00082589
First received: May 12, 2004
Last updated: May 22, 2008
Last verified: April 2007

May 12, 2004
May 22, 2008
April 2004
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Difference between eplerenone and placebo in change from baseline in LV end diastolic volume index (EDVi) determined by equilibrium-gated radionuclide ventriculography (RVG)
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Complete list of historical versions of study NCT00082589 on ClinicalTrials.gov Archive Site
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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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Heart Failure, Congestive
Drug: Eplerenone
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
March 2006
Not Provided

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00082589
A6141078
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Pfizer
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Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP