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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
221
Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
Placebo once daily or every once daily
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.
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) 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.
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
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.
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Chubu Rosai Hospital
Nagoya, Aichi-ken, Japan
Tosei General Hospital
Seto, Aichi-ken, Japan
Asahi General Hospital
Asahi, Chiba, Japan
National Hospital Organization Chiba Medical Center
Chiba, Chiba, Japan
Nippon Medical School Chiba Hokusou Hospital
Inzai, Chiba, Japan
Ehime Prefectural Central Hospital
Matuyama-shi, Ehime, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Aso Iizuka Hospital
Iizuka-shi, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
Kōriyama, Fukushima, Japan
...and 44 more locations
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
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)
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.
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)
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)
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.
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
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)
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.
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
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)
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.
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)
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)
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.
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
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)
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.
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
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)
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
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)
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
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)
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.
Time frame: Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)