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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Eplerenone
Placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Double-blind, eplerenone, Japanese

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chubu Rosai Hospital
  • Tosei General Hospital
  • National Hospital Organization Chiba Medical Center
  • Asahi General Hospital
  • Nippon Medical School Chiba Hokusou Hospital
  • Ehime Prefectural Central Hospital
  • Kyushu University Hospital
  • Aso Iizuka Hospital
  • Kurume University Hospital
  • Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
  • Ogaki Municipal Hospital
  • National Hospital Organization Hakodate National Hospital
  • Hakodate City Hospital
  • Teine Keijinkai Clinic
  • Hokkaido University Hospital
  • National Hospital Organization Hokkaido Medical Center
  • Hyogo Brain and Heart Center
  • Japanease Red Cross Society Himeji Hospital
  • The Hospital of Hyogo College of Medicine
  • Toride Kyodo General Hospital
  • Mitoyo General Hospital
  • Fujisawa City Hospital
  • Kitasato University Hospital
  • Mie University Hospital
  • National Hospital Organization Sendai Medical Center
  • Nara Medical University Hospital
  • National Cerebral and Cardiovascular Center Hospital
  • Kishiwada Tokushukai Hospital
  • Sakai City Medical Center
  • Gokeikai Osaka Kaisei Hospital
  • Shuwa General Hospital
  • Saitama Medical Center Jichi Medical University
  • Kusatsu General Hospital
  • Hamamatsu Rosai Hospital
  • Jichi Medical University Hospital
  • Tokushima Red Cross Hospital
  • Juntendo University Hospital
  • Mitsui Memorial Hospital
  • Tokyo Women's Medical University Hospital
  • Tottori University Hospital
  • Ube-kohsan Central Hospital Corp.
  • Yamaguchi University Hospital
  • University of Yamanashi Hospital
  • Hamanomachi Hospital
  • Fukushima Medical University Hospital
  • Gifu Prefectural General Medical Center
  • Kumamoto University Hospital
  • Saiseikai Kumamoto Hospital
  • Japanese Red Cross Okayama Hospital
  • National Hospital Organization Osaka National Hospital
  • Osaka Police Hospital
  • Osaka General Medical Center
  • National Hospital Organization Takasaki General Medical Center
  • Toyama University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eplerenone arm

Placebo arm

Arm Description

Add on standard heart failure therapy

Add on standard heart failure therapy

Outcomes

Primary Outcome Measures

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)
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.

Secondary Outcome Measures

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication
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
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
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
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)
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
April 30, 2010
Last Updated
December 19, 2020
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01115855
Brief Title
Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure
Acronym
J-EMPHASIS-HF
Official Title
The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Japanese Subjects With Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Double-blind, eplerenone, Japanese

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eplerenone arm
Arm Type
Experimental
Arm Description
Add on standard heart failure therapy
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Add on standard heart failure therapy
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Intervention Description
Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily or every once daily
Primary Outcome Measure Information:
Title
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Secondary Outcome Measure Information:
Title
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With With First Occurrence of All-Cause Mortality
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With With First Occurrence of Cardiovascular Mortality
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of All-cause Hospitalization
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF)
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke
Description
Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI)
Description
Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of New Onset Diabetes Mellitus
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
Number of Participants With First Occurrence of Hospitalization for Hyperkalemia
Description
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.
Time Frame
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Title
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)
Title
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)
Title
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
Description
LVEF was calculated based on end-diastolic volume measured by two-dimensional echocardiography.
Time Frame
Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)
Title
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)
Title
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
Description
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).
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)
Title
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
Description
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.
Time Frame
Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Chubu Rosai Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Tosei General Hospital
City
Seto
State/Province
Aichi
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
National Hospital Organization Chiba Medical Center
City
Chiba-shi
State/Province
Chiba-ken
ZIP/Postal Code
260-8606
Country
Japan
Facility Name
Asahi General Hospital
City
Asahi
State/Province
Chiba
ZIP/Postal Code
289-2511
Country
Japan
Facility Name
Nippon Medical School Chiba Hokusou Hospital
City
Inzai
State/Province
Chiba
ZIP/Postal Code
270-1694
Country
Japan
Facility Name
Ehime Prefectural Central Hospital
City
Matuyama-shi
State/Province
Ehime
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka-shi
State/Province
Fukuoka-ken
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Aso Iizuka Hospital
City
Iizuka-shi
State/Province
Fukuoka-ken
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka-ken
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8052
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Facility Name
National Hospital Organization Hakodate National Hospital
City
Hakodate-shi
State/Province
Hokkai-do
ZIP/Postal Code
041-8512
Country
Japan
Facility Name
Hakodate City Hospital
City
Hakodate
State/Province
Hokkaido
ZIP/Postal Code
041-8680
Country
Japan
Facility Name
Teine Keijinkai Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-0811
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
National Hospital Organization Hokkaido Medical Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0005
Country
Japan
Facility Name
Hyogo Brain and Heart Center
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-0981
Country
Japan
Facility Name
Japanease Red Cross Society Himeji Hospital
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-8540
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Toride Kyodo General Hospital
City
Toride-shi
State/Province
Ibaraki
ZIP/Postal Code
302-0022
Country
Japan
Facility Name
Mitoyo General Hospital
City
Kannonji
State/Province
Kagawa
ZIP/Postal Code
769-1695
Country
Japan
Facility Name
Fujisawa City Hospital
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-8550
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Mie University Hospital
City
Tsu
State/Province
MIE
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai-shi
State/Province
Miyagi-ken
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center Hospital
City
Suita-shi
State/Province
Osaka-fu
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
State/Province
Osaka
ZIP/Postal Code
596-0042
Country
Japan
Facility Name
Sakai City Medical Center
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
593-8304
Country
Japan
Facility Name
Gokeikai Osaka Kaisei Hospital
City
Yodogawa-ku
State/Province
Osaka
ZIP/Postal Code
532-0003
Country
Japan
Facility Name
Shuwa General Hospital
City
Kasukabe-shi
State/Province
Saitama
ZIP/Postal Code
344-0035
Country
Japan
Facility Name
Saitama Medical Center Jichi Medical University
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
330-0834
Country
Japan
Facility Name
Kusatsu General Hospital
City
Kusatsu-shi
State/Province
Shiga-ken
ZIP/Postal Code
525-8585
Country
Japan
Facility Name
Hamamatsu Rosai Hospital
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
430-8525
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke-shi
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Tokushima Red Cross Hospital
City
Komatsushima
State/Province
Tokushima
ZIP/Postal Code
773-8502
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Mitsui Memorial Hospital
City
Chiyoda-Ku
State/Province
Tokyo
ZIP/Postal Code
101-8643
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Tottori University Hospital
City
Yonago-shi
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Ube-kohsan Central Hospital Corp.
City
Ube-city
State/Province
Yamaguchi
ZIP/Postal Code
755-0151
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
University of Yamanashi Hospital
City
Chuo
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Facility Name
Hamanomachi Hospital
City
Fukuoka
ZIP/Postal Code
810-8539
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Gifu Prefectural General Medical Center
City
Gifu
ZIP/Postal Code
500-8727
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-4101
Country
Japan
Facility Name
Japanese Red Cross Okayama Hospital
City
Okayama
ZIP/Postal Code
700-8607
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka Police Hospital
City
Osaka
ZIP/Postal Code
543-0035
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
National Hospital Organization Takasaki General Medical Center
City
Takasaki-shi
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
Toyama University Hospital
City
Toyama
ZIP/Postal Code
930-0152
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28824029
Citation
Tsutsui H, Ito H, Kitakaze M, Komuro I, Murohara T, Izumi T, Sunagawa K, Yasumura Y, Yano M, Yamamoto K, Yoshikawa T, Tsutamoto T, Zhang J, Okayama A, Ichikawa Y, Kanmuri K, Matsuzaki M; J-EMPHASIS-HF Study Group. Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Eplerenone in Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF). Circ J. 2017 Dec 25;82(1):148-158. doi: 10.1253/circj.CJ-17-0323. Epub 2017 Aug 19.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6141114&StudyName=Clinical%20Study%20Of%20Eplerenone%20In%20Japanese%20Patients%20With%20Chronic%20Heart%20Failure%20
Description
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Learn more about this trial

Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure

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