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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT00232180
Date of registration:	30/09/2005
Prospective Registration:	Yes
Primary sponsor:	Pfizer
Public title:	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
Scientific title:	The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure
Date of first enrolment:	March 2006
Target sample size:	2743
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00232180
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Argentina	Australia	Belgium	Canada	Czech Republic	Czechia	Egypt	France
Germany	Greece	Hong Kong	Hungary	India	Ireland	Italy	Jordan
Korea, Republic of	Lebanon	Mexico	Netherlands	Poland	Portugal	Russian Federation	Singapore
Slovakia	South Africa	Spain	Sweden	Ukraine	United Arab Emirates	United Kingdom	United States
Venezuela

Contacts

Name:	Pfizer CT.gov Call Center
Address:
Telephone:
Email:
Affiliation:	Pfizer

Key inclusion & exclusion 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. Should have participated in the double-blind phase of the
EMPHASIS-HF trial

Exclusion Criteria:

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

Age minimum: 55 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Drug: Eplerenone

Primary Outcome(s)

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)]

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)]

Secondary Outcome(s)

Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With New Onset Atrial Fibrillation or Flutter [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With New Onset Diabetes Mellitus (DM) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated) [Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)]

Secondary ID(s)

A6141079

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	27/06/2011
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00232180

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