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Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01115855
First received: April 30, 2010
Last updated: September 5, 2016
Last verified: September 2016
April 30, 2010
September 5, 2016
July 2010
September 2015   (Final data collection date for primary outcome measure)
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
First occurrence of cardiovascular mortality or heart failure hospitalization [ Time Frame: 4 years ]
Complete list of historical versions of study NCT01115855 on ClinicalTrials.gov Archive Site
  • Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percentage (%) or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With With First Occurrence of All-Cause Mortality [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Mortality during treatment, within 30 days of treatment discontinuation and after 30 days of discontinuation was reported. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With With First Occurrence of Cardiovascular Mortality [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of All-cause Hospitalization [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    All cause hospitalization included all hospitalizations as CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris and non-CV hospitalizations which was defined as any hospitalization due to non-CV events including renal dysfunction, hyperkalaemia, malignant tumor and pulmonary disease. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF) [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    All cause hospitalization included all hospitalizations as CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris and non-CV hospitalizations which was defined as any hospitalization due to non-CV events including renal dysfunction, hyperkalaemia, malignant tumor and pulmonary disease. All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    HF mortality was defined as any death due to HF. Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percent or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI) [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    New onset of atrial fibrillation or flutter was defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of New Onset Diabetes Mellitus [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    New onset diabetes mellitus was defined as the diagnosis of diabetes mellitus in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    Hospitalization due to worsening renal function (as per physician's decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Number of Participants With First Occurrence of Hospitalization for Hyperkalemia [ Time Frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days) ]
    Hospitalization due to hyperkalemia (as per physician's decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
  • Change From Baseline in Plasma Concentration of Brain Natriuretic Peptide at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit [ Time Frame: Baseline, Months 5,9,13,17,21,25,29,33,37,42,48, Final Visit (up to Month 48) ]
  • Change From Baseline in Plasma Concentration of Serum N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit [ Time Frame: Baseline, Months 5, 9, 13, 17, 21 ,25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48) ]
  • Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit [ Time Frame: Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48) ]
    LVEF was calculated based on end-diastolic volume measured by two-dimensional echocardiography.
  • Change From Baseline in Urine Albumin-to-Creatinine Ratio at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit [ Time Frame: Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48) ]
  • Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit [ Time Frame: Baseline, Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48) ]
    NYHA: classified as 'class I' (participants with cardiac disease but without resulting limitations of physical activity), 'class II' (participants with cardiac disease resulting in slight limitation of physical activity), 'class III' (participants with cardiac disease resulting in marked limitation of physical activity), 'class IV' (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). Participants with change from baseline were classified as 'improved' (positive change), 'no change' or 'worsened' (negative change).
  • Change From Baseline in Specific Activity Scale (SAS) Score at Week 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit [ Time Frame: Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48) ]
    Specific activity scale was estimated by pre-specified questionnaire (for different activities) to assess the exercise capability of the participants. Answers provided by participants were transformed in terms of number of metabolic equivalents (METs).1 MET was defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml oxygen per kg body weight* minute. Scale ranged from 1 (less than (<) 2 METs) = lowest level of exercise tolerance to 6 (>=8METs) = highest level of tolerance and higher score indicated more tolerance.
  • First occurrence of Cardiovascular (CV) mortality, heart failure (HF) hospitalization or Addition/Increase of HF medication due to HF worsening [ Time Frame: 4 years ]
  • All-cause mortality [ Time Frame: 4 years ]
  • CV mortality [ Time Frame: 4 years ]
  • All-cause hospitalization [ Time Frame: 4 years ]
  • HF hospitalization [ Time Frame: 4 years ]
  • All-cause mortality or all-cause hospitalization [ Time Frame: 4 years ]
  • HF mortality or HF hospitalization [ Time Frame: 4 years ]
  • CV hospitalization [ Time Frame: 4 years ]
  • Addition/Increase of HF medication due to HF worsening [ Time Frame: 4 years ]
  • Fatal/non-fatal myocardial infarction [ Time Frame: 4 years ]
  • Fatal/non-fatal stroke [ Time Frame: 4 years ]
  • New onset atrial fibrillation/flutter [ Time Frame: 4 years ]
  • New onset diabetes mellitus [ Time Frame: 4 years ]
  • Worsening renal function (if it results in hospitalization) [ Time Frame: 4 years ]
  • Hospitalization for hyperkalemia [ Time Frame: 4 years ]
  • Plasma BNP, Serum nt-BNP [ Time Frame: 4 years ]
  • LVEF [ Time Frame: 4 years ]
  • NYHA classification [ Time Frame: 4 years ]
  • Specific activity scale (SAS) [ Time Frame: 4 years ]
Not Provided
Not Provided
 
Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure
The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Japanese Subjects With Chronic Heart Failure
A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo.
The aim of this study was to show consistency with the EMPHASIS-HF trial (NCT00232180), which was defined as a HR of the primary endpoint of below 1.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Drug: Eplerenone
    Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
  • Drug: Placebo
    Placebo once daily or every once daily
  • Experimental: Eplerenone arm
    Add on standard heart failure therapy
    Intervention: Drug: Eplerenone
  • Placebo Comparator: Placebo arm
    Add on standard heart failure therapy
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
September 2015
September 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Japanese chronic systolic heart failure patients with LVEF =<30% by echocardiography and NYHA II or more
  • Patients who receive standard therapy (Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blocker or diuretic)

Exclusion Criteria:

  • Patients with a myocardial infarction, stroke, cardiac surgery or percutaneous coronary intervention within 30 days prior to randomization.
  • Patients with serum potassium >5.0 mmol/L or eGFR <30 ml/min/1.73 m2.
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01115855
A6141114
Yes
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2016

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