A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines (EMPHASIS-HF)


Tracking Information

Start Date  ICMJEMarch 2006
Estimated Primary Completion DateOctober 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2009)		Cardiovascular mortality or heart failure hospitalization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: September 30, 2005)		Cardiovascular mortality or heart failure hospitalization
Change HistoryComplete list of historical versions of study NCT00232180 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 19, 2007)		All cause mortality or heart failure hospitalization; cardiovascular mortality; heart failure hospitalization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: September 30, 2005)		All cause mortality or heart failure hospitalization; cardiovascular mortality; heart failure hospitalization

Descriptive Information

Brief Title  ICMJEA Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
Official Title  ICMJEThe Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEHeart Failure
Intervention  ICMJE
  • Drug: Eplerenone
    Eplerenone administered on top of background standard heart failure therapy
  • Drug: Placebo
    Placebo administered on top of background standard heart failure therapy
Study Arms / Comparison Groups
  • Eplerenone arm: Active Comparator
    Eplerenone administered on top of background standard heart failure therapy
    Intervention: Drug: Eplerenone
  • Placebo arm: Placebo Comparator
    Placebo administered on top of background standard heart failure therapy
    Intervention: Drug: Placebo

Recruitment Information

Recruitment Status  ICMJERecruiting
Estimated Enrollment  ICMJE3100
Estimated Completion DateOctober 2011
Estimated Primary Completion DateOctober 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages55 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Ireland,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Ukraine,   United Arab Emirates,   United Kingdom,   Venezuela

Administrative Information

NCT ID  ICMJENCT00232180
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer
Study ID Numbers  ICMJEA6141079
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer