Heart FailurePhase 3J-EMPHASIS-HFNCT01115855
Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure
A Phase 3 study testing Eplerenone in people with Heart Failure, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 54 sites in Japan.
Trial summary
A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 221 participants
- Where
- 54 sitesJapan
- Study dates
- Jul 2010to Sep 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Japan54 sites
Asahi General Hospital
Asahi, Chiba, 289-2511
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
National Hospital Organization Chiba Medical Center
Chiba, Chiba, 260-8606
Mitsui Memorial Hospital
Chiyoda-Ku, Tokyo, 101-8643
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898
Fujisawa City Hospital
Fujisawa, Kanagawa, 251-8550
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Hamanomachi Hospital
Fukuoka, 810-8539
Fukushima Medical University Hospital
Fukushima, 960-1295
Gifu Prefectural General Medical Center
Gifu, 500-8727
Hakodate City Hospital
Hakodate, Hokkaido, 041-8680
National Hospital Organization Hakodate National Hospital
Hakodate-shi, Hokkai-do, 041-8512
Hamamatsu Rosai Hospital
Hamamatsu, Shizuoka, 430-8525
Hyogo Brain and Heart Center
Himeji, Hyōgo, 670-0981
Japanease Red Cross Society Himeji Hospital
Himeji, Hyōgo, 670-8540
Aso Iizuka Hospital
Iizuka-shi, Fukuoka, 820-8505
Nippon Medical School Chiba Hokusou Hospital
Inzai, Chiba, 270-1694
Mitoyo General Hospital
Kan’onjichō, Kagawa-ken, 769-1695
Nara Medical University Hospital
Kashihara, Nara, 634-8522
Shuwa General Hospital
Kasukabe-shi, Saitama, 344-0035
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-0042
Tokushima Red Cross Hospital
Komatsushimachō, Tokushima, 773-8502
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
Kōriyama, Fukushima, 963-8052
Kumamoto University Hospital
Kumamoto, 860-8556
Saiseikai Kumamoto Hospital
Kumamoto, 861-4101
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
Kusatsu General Hospital
Kusatsu-shi, Shiga, 525-8585
Ehime Prefectural Central Hospital
Matuyama-shi, Ehime, 790-0024
Chubu Rosai Hospital
Nagoya, Aichi-ken, 455-8530
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501
Ogaki Municipal Hospital
Ōgaki, Gifu, 503-8502
Japanese Red Cross Okayama Hospital
Okayama, 700-8607
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
Osaka Police Hospital
Osaka, 543-0035
Osaka General Medical Center
Osaka, 558-8558
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375
Saitama Medical Center Jichi Medical University
Saitama-shi, Saitama, 330-0834
Sakai City Medical Center
Sakai-shi, Osaka, 593-8304
Teine Keijinkai Clinic
Sapporo, Hokkaido, 006-0811
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
National Hospital Organization Hokkaido Medical Center
Sapporo, Hokkaido, 063-0005
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 983-8520
Tosei General Hospital
Seto, Aichi-ken, 489-8642
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, 329-0498
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
National Cerebral and Cardiovascular Center Hospital
Suita-shi, Osaka, 565-8565
National Hospital Organization Takasaki General Medical Center
Takasaki-shi, 370-0829
Toride Kyodo General Hospital
Toride-shi, Ibaraki, 302-0022
Toyama University Hospital
Toyama, 930-0152
Mie University Hospital
Tsu, Mie-ken, 514-8507
Ube-kohsan Central Hospital Corp.
Ube, Yamaguchi, 755-0151
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505
Gokeikai Osaka Kaisei Hospital
Yodogawa-ku, Osaka, 532-0003
Tottori University Hospital
Yonago-shi, Tottori, 683-8504
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Eplerenone, Placebo
- Keywords
- Double-blind, eplerenone, Japanese
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
PlaceboDrug
Placebo once daily or every once daily
| Study group | Role | What they receive |
|---|---|---|
| Eplerenone arm | Experimental | Add on standard heart failure therapy Receives: Drug: Eplerenone |
| Placebo arm | Placebo comparator | Add on standard heart failure therapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Secondary outcomes (21)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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.
Measured: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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
Measured: 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
Measured: 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
LVEF was calculated based on end-diastolic volume measured by two-dimensional echocardiography.
Measured: Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)
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
Measured: 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
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).
Measured: 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)
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.
Measured: Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115855
- Sponsor's protocol ID
- A6141114
- Acronym
- J-EMPHASIS-HF
- Status last verified
- Dec 2020
- First submitted
- 30 Apr 2010
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28824029
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Japanese Subjects With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01115855
- Acronym / sponsor ID
- J-EMPHASIS-HF / A6141114
- Conditions
- Heart Failure
- Keywords
- Double-blind, eplerenone, Japanese
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Posted 27 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eplerenone arm | Experimental | Drug: EplerenoneAdd on standard heart failure therapy |
| Placebo arm | Placebo comparator | Drug: PlaceboAdd on standard heart failure therapy |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EplerenoneEplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily | Drug | Eplerenone arm |
| PlaceboPlacebo once daily or every once daily | Drug | Placebo arm |
Primary outcome
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.
21 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28824029Tsutsui 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eplerenone in people with Heart Failure, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 54 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01115855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.