A Comparison of Outcomes in Patients in NYHA Class II Heart Failure When Treated With Eplerenone or Placebo in Addition to Standard Heart Failure Medicines - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00232180

Purpose

In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients

Condition	Intervention	Phase
Heart Failure	Drug: Eplerenone Drug: Placebo	Phase III

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Eplerenone Versus Placebo on Cardiovascular Mortality and Heart Failure Hospitalization in Subjects With NYHA Class II Chronic Systolic Heart Failure

Further study details as provided by Pfizer:

Primary Outcome Measures:

Cardiovascular mortality or heart failure hospitalization [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All cause mortality or heart failure hospitalization; cardiovascular mortality; heart failure hospitalization [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	2584
Study Start Date:	March 2006
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Eplerenone arm: Active Comparator Eplerenone administered on top of background standard heart failure therapy	Drug: Eplerenone Eplerenone administered on top of background standard heart failure therapy
Placebo arm: Placebo Comparator Placebo administered on top of background standard heart failure therapy	Drug: Placebo Placebo administered on top of background standard heart failure therapy

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History (Hx) of chronic systolic heart failure of ischemic or non-ischemic etiology of at least 4 weeks duration; Currently, New York Heart Association (NYHA) functional Class II and on optimal dose, or maximally tolerated dose of standard heart failure medicines (advisable to include ACE-I/ARBs; beta-blockers and diuretics if indicated for fluid overload

Exclusion Criteria:

Severe chronic systolic heart failure symptomatic at rest despite optimal medical therapy; estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232180

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 298 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6141079
Study First Received:	September 30, 2005
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00232180
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Double-blind, parallel group, mortality/morbidity trial, eplerenone, chronic systolic heart failure

Study placed in the following topic categories:

Eplerenone
Heart Failure
Heart Diseases
Heart Failure, Systolic

Additional relevant MeSH terms:

Aldosterone Antagonists
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009