Heart Failure
Conditions
Keywords
Double-blind, eplerenone, Japanese
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.
Interventions
DRUGEplerenone
Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
DRUGPlacebo
Placebo once daily or every once daily
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With With First Occurrence of All-Cause Mortality | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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) | 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 Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication | 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 First Occurrence of New Onset Diabetes Mellitus | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eplerenone Participants with eGFR \>=50 mL/min/1.73m\^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to \< 50 mL/min/1.73m\^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR \>=50 mL/min/1.73 m\^2 and 25 mg once daily for participants with eGFR 30 to \<50 mL/min/1.73 m\^2 up to Month 48. | 111 |
| Placebo Participants with eGFR \>=50 mL/min/1.73m\^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to \<50 mL/min/1.73m\^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48. | 110 |
| Total | 221 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 16 | 18 |
| Overall Study | Death | 6 | 5 |
| Overall Study | Lab Abnormality | 1 | 1 |
| Overall Study | Other | 8 | 6 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | Eplerenone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 69.0 years STANDARD_DEVIATION 8.7 | 68.4 years STANDARD_DEVIATION 7.7 | 68.7 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male FEMALE | 26 Participants | 19 Participants | 45 Participants |
| Sex: Female, Male MALE | 85 Participants | 91 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 89 / 111 | 87 / 110 |
| serious Total, serious adverse events | 52 / 111 | 65 / 110 |
Outcome results
Primary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) | 33 participants |
| Placebo | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) | 36 participants |
Comparison: Cox Proportional Hazard Model with baseline New York Heart Association (NYHA) cohort (II, III/IV) and baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) covariates.95% CI: [0.53, 1.36]
Secondary
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)
Population: Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone | 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 | Change at Month 9 (n=99,104) | 33.89 percentage of LVEF | Standard Deviation 10.64 |
| Eplerenone | 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 | Change at Month 29 (n=53,48) | 11.95 percentage of LVEF | Standard Deviation 12.28 |
| Eplerenone | 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 | Change at Month 17 (n=81,82) | 11.36 percentage of LVEF | Standard Deviation 11.45 |
| Eplerenone | 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 | Change at Month 33 (n=45,39) | 13.67 percentage of LVEF | Standard Deviation 13.94 |
| Eplerenone | 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 | Change at Month 5 (n=105,106) | 5.98 percentage of LVEF | Standard Deviation 8.87 |
| Eplerenone | 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 | Change at Month 37 (n=40,33) | 13.34 percentage of LVEF | Standard Deviation 14.59 |
| Eplerenone | 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 | Change at Month 21 (n=72,73) | 12.73 percentage of LVEF | Standard Deviation 12.04 |
| Eplerenone | 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 | Change at Month 42 (n=30,26) | 12.15 percentage of LVEF | Standard Deviation 14.38 |
| Eplerenone | 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 | Change at Month 13 (n=94,101) | 9.62 percentage of LVEF | Standard Deviation 9.7 |
| Eplerenone | 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 | Change at Month 48 (n=16,16) | 10.18 percentage of LVEF | Standard Deviation 16.02 |
| Eplerenone | 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 | Change at Month 25 (n=63,64) | 12.18 percentage of LVEF | Standard Deviation 12.18 |
| Eplerenone | 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 | Change at Final Visit (n=109,110) | 9.50 percentage of LVEF | Standard Deviation 12.03 |
| Eplerenone | 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 | Baseline (n=111,110) | 25.64 percentage of LVEF | Standard Deviation 4.95 |
| Placebo | 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 | Change at Final Visit (n=109,110) | 5.99 percentage of LVEF | Standard Deviation 11.04 |
| Placebo | 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 | Baseline (n=111,110) | 26.64 percentage of LVEF | Standard Deviation 3.97 |
| Placebo | 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 | Change at Month 5 (n=105,106) | 4.01 percentage of LVEF | Standard Deviation 7.59 |
| Placebo | 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 | Change at Month 9 (n=99,104) | 31.37 percentage of LVEF | Standard Deviation 9.19 |
| Placebo | 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 | Change at Month 13 (n=94,101) | 4.86 percentage of LVEF | Standard Deviation 10.13 |
| Placebo | 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 | Change at Month 17 (n=81,82) | 5.50 percentage of LVEF | Standard Deviation 10.74 |
| Placebo | 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 | Change at Month 21 (n=72,73) | 6.37 percentage of LVEF | Standard Deviation 11.88 |
| Placebo | 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 | Change at Month 25 (n=63,64) | 6.60 percentage of LVEF | Standard Deviation 10.94 |
| Placebo | 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 | Change at Month 29 (n=53,48) | 6.45 percentage of LVEF | Standard Deviation 12.83 |
| Placebo | 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 | Change at Month 33 (n=45,39) | 5.20 percentage of LVEF | Standard Deviation 10.19 |
| Placebo | 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 | Change at Month 37 (n=40,33) | 7.18 percentage of LVEF | Standard Deviation 10.49 |
| Placebo | 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 | Change at Month 42 (n=30,26) | 5.13 percentage of LVEF | Standard Deviation 10.36 |
| Placebo | 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 | Change at Month 48 (n=16,16) | 8.41 percentage of LVEF | Standard Deviation 11.51 |
Comparison: Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.55, 3.96]
Comparison: Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [0.07, 5.42]
Comparison: Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [1.11, 6.6]
Comparison: Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [1.81, 7.9]
Comparison: Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [2.36, 8.94]
Comparison: Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [0.12, 6.75]
Comparison: Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.06, 7.25]
Comparison: Change from baseline at Month 33 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [0.86, 8.44]
Comparison: Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [0.02, 7.68]
Comparison: Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.90% CI: [0.08, 9.25]
Comparison: Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-1.82, 10.07]
Comparison: Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [0.56, 5.8]
Secondary
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)
Population: Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone | 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 at Month 9 (n=99,104) | -208.54 picogram/milliliter (pg/ml) | Standard Deviation 405.74 |
| Eplerenone | 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 at Month 29 (n=53,48) | -269.07 picogram/milliliter (pg/ml) | Standard Deviation 502.78 |
| Eplerenone | 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 at Month 17 (n=81,82) | -242.92 picogram/milliliter (pg/ml) | Standard Deviation 431.59 |
| Eplerenone | 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 at Month 33 (n=45,40) | -228.84 picogram/milliliter (pg/ml) | Standard Deviation 575.05 |
| Eplerenone | 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 at Month 5 (n=105,106) | -169.75 picogram/milliliter (pg/ml) | Standard Deviation 424.4 |
| Eplerenone | 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 at Month 37 (n=40,33) | -211.86 picogram/milliliter (pg/ml) | Standard Deviation 597.3 |
| Eplerenone | 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 at Month 21 (n=72,73) | -241.33 picogram/milliliter (pg/ml) | Standard Deviation 429.24 |
| Eplerenone | 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 at Month 42 (n=30,26) | -155.65 picogram/milliliter (pg/ml) | Standard Deviation 320.44 |
| Eplerenone | 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 at Month 13 (n=95,101) | -258.66 picogram/milliliter (pg/ml) | Standard Deviation 395.05 |
| Eplerenone | 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 at Month 48 (n=16,16) | -200.85 picogram/milliliter (pg/ml) | Standard Deviation 357.51 |
| Eplerenone | 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 at Month 25 (n=63,63) | -249.76 picogram/milliliter (pg/ml) | Standard Deviation 473.68 |
| Eplerenone | 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 at Final Visit (n=109,110) | -149.75 picogram/milliliter (pg/ml) | Standard Deviation 473.95 |
| Eplerenone | 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 | Baseline (n=111,110) | 469.29 picogram/milliliter (pg/ml) | Standard Deviation 375.43 |
| Placebo | 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 at Final Visit (n=109,110) | -57.45 picogram/milliliter (pg/ml) | Standard Deviation 509.85 |
| Placebo | 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 | Baseline (n=111,110) | 435.61 picogram/milliliter (pg/ml) | Standard Deviation 391.49 |
| Placebo | 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 at Month 5 (n=105,106) | -36.36 picogram/milliliter (pg/ml) | Standard Deviation 413.73 |
| Placebo | 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 at Month 9 (n=99,104) | -76.23 picogram/milliliter (pg/ml) | Standard Deviation 442.47 |
| Placebo | 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 at Month 13 (n=95,101) | -93.99 picogram/milliliter (pg/ml) | Standard Deviation 409.87 |
| Placebo | 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 at Month 17 (n=81,82) | -69.74 picogram/milliliter (pg/ml) | Standard Deviation 535.05 |
| Placebo | 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 at Month 21 (n=72,73) | -57.31 picogram/milliliter (pg/ml) | Standard Deviation 515.76 |
| Placebo | 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 at Month 25 (n=63,63) | -83.99 picogram/milliliter (pg/ml) | Standard Deviation 506.79 |
| Placebo | 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 at Month 29 (n=53,48) | -95.33 picogram/milliliter (pg/ml) | Standard Deviation 350.51 |
| Placebo | 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 at Month 33 (n=45,40) | -43.98 picogram/milliliter (pg/ml) | Standard Deviation 500.78 |
| Placebo | 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 at Month 37 (n=40,33) | -73.73 picogram/milliliter (pg/ml) | Standard Deviation 626.13 |
| Placebo | 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 at Month 42 (n=30,26) | -22.31 picogram/milliliter (pg/ml) | Standard Deviation 689.26 |
| Placebo | 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 at Month 48 (n=16,16) | -122.33 picogram/milliliter (pg/ml) | Standard Deviation 450.87 |
Comparison: Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-195.92, -9.94]
Comparison: Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-184.51, -7.04]
Comparison: Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-195.5, -54.68]
Comparison: Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-232.77, -31.11]
Comparison: Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-240.94, -23.84]
Comparison: Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-221.49, -12.87]
Comparison: Change from baseline at Month 29 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-267.36, 64.36]
Comparison: Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-307.49, 85.93]
Comparison: Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-2137.82, 1898.59]
Comparison: Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.90% CI: [-2692.95, 2403.76]
Comparison: Change from baseline at Month 48 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-2131.88, 1977.37]
Comparison: Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-172.61, -32]
Secondary
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)
Population: Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone | 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 at Month 37 (n=40,33) | -9.64 pg/mL | Standard Deviation 5188.24 |
| Eplerenone | 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 | Baseline (n=111,110) | 2635.78 pg/mL | Standard Deviation 2143.64 |
| Eplerenone | 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 at Month 5 (n=105,106) | -770.51 pg/mL | Standard Deviation 2172.88 |
| Eplerenone | 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 at Month 9 (n=99,104) | -884.76 pg/mL | Standard Deviation 2265.57 |
| Eplerenone | 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 at Month 13 (n=95,101) | -1066.86 pg/mL | Standard Deviation 2088.51 |
| Eplerenone | 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 at Month 17 (n=81,82) | -1126.96 pg/mL | Standard Deviation 2384.14 |
| Eplerenone | 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 at Month 21 (n=72,73) | -957.86 pg/mL | Standard Deviation 2601.47 |
| Eplerenone | 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 at Month 25 (n=63,63) | -453.57 pg/mL | Standard Deviation 4894.51 |
| Eplerenone | 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 at Month 29 (n=53,48) | -1013.83 pg/mL | Standard Deviation 3167.91 |
| Eplerenone | 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 at Month 33 (n=45,40) | -168.36 pg/mL | Standard Deviation 5404.82 |
| Eplerenone | 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 at Month 42 (n=30,26) | -246.77 pg/mL | Standard Deviation 4753.87 |
| Eplerenone | 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 at Month 48 (n=16,16) | -970.71 pg/mL | Standard Deviation 4833.6 |
| Eplerenone | 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 at Final Visit (n=109,110) | -177.00 pg/mL | Standard Deviation 3780.44 |
| Placebo | 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 at Month 48 (n=16,16) | -450.69 pg/mL | Standard Deviation 1487.78 |
| Placebo | 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 at Month 25 (n=63,63) | -128.02 pg/mL | Standard Deviation 2627.01 |
| Placebo | 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 | Baseline (n=111,110) | 2354.31 pg/mL | Standard Deviation 1874.3 |
| Placebo | 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 at Month 42 (n=30,26) | 928.35 pg/mL | Standard Deviation 6494.32 |
| Placebo | 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 at Month 5 (n=105,106) | -205.18 pg/mL | Standard Deviation 1801.42 |
| Placebo | 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 at Month 29 (n=53,48) | -187.08 pg/mL | Standard Deviation 2524.52 |
| Placebo | 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 at Month 9 (n=99,104) | -425.47 pg/mL | Standard Deviation 1883.54 |
| Placebo | 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 at Final Visit (n=109,110) | 296.35 pg/mL | Standard Deviation 3823.59 |
| Placebo | 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 at Month 13 (n=95,101) | -452.02 pg/mL | Standard Deviation 1878.98 |
| Placebo | 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 at Month 33 (n=45,40) | 434.35 pg/mL | Standard Deviation 5134.98 |
| Placebo | 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 at Month 17 (n=81,82) | -109.59 pg/mL | Standard Deviation 3380.42 |
| Placebo | 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 at Month 37 (n=40,33) | 171.21 pg/mL | Standard Deviation 5081.43 |
| Placebo | 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 at Month 21 (n=72,73) | -250.85 pg/mL | Standard Deviation 2508.01 |
Comparison: Change from baseline at Month 5 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-1863.06, 1133.76]
Comparison: Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-1642.43, 1148.14]
Comparison: Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-1742.51, 1002.22]
Comparison: Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-141189.93, 139861.75]
Comparison: Change from baseline at Month 21 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-39445.52, 38615.54]
Comparison: Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-21649.89, 21697.6]
Comparison: Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-85358.69, 84868.22]
Comparison: Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-21375.69, 21716.66]
Comparison: Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-30160.25, 30042.7]
Comparison: Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.90% CI: [-22723.82, 22299.33]
Comparison: Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-146026.28, 145865.96]
Comparison: Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-662.67, 287.23]
Secondary
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)
Population: Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone | 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 | Baseline (n=111,110) | 4.85 metabolic equivalents (METs) | Standard Deviation 1.51 |
| Eplerenone | 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 | Change at Week 4 (n= 111,108) | 0.15 metabolic equivalents (METs) | Standard Deviation 0.79 |
| Eplerenone | 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 | Change at Month 5 (n=104,106) | 0.46 metabolic equivalents (METs) | Standard Deviation 1.15 |
| Eplerenone | 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 | Change at Month 9 (n=99,104) | 0.41 metabolic equivalents (METs) | Standard Deviation 1.16 |
| Eplerenone | 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 | Change at Month 13 (n=94,102) | 0.52 metabolic equivalents (METs) | Standard Deviation 1.18 |
| Eplerenone | 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 | Change at Month 17 (n=81,82) | 0.46 metabolic equivalents (METs) | Standard Deviation 1.38 |
| Eplerenone | 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 | Change at Month 21 (n=72,73) | 0.34 metabolic equivalents (METs) | Standard Deviation 1.33 |
| Eplerenone | 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 | Change at Month 25 (n=63,63) | 0.48 metabolic equivalents (METs) | Standard Deviation 1.08 |
| Eplerenone | 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 | Change at Month 29 (n=53,48) | 0.42 metabolic equivalents (METs) | Standard Deviation 1.14 |
| Eplerenone | 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 | Change at Month 33 (n=46,40) | 0.37 metabolic equivalents (METs) | Standard Deviation 1.28 |
| Eplerenone | 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 | Change at Month 37 (n=40,33) | 0.53 metabolic equivalents (METs) | Standard Deviation 1.47 |
| Eplerenone | 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 | Change at Month 42 (n=30,26) | 0.39 metabolic equivalents (METs) | Standard Deviation 1.7 |
| Eplerenone | 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 | Change at Month 48 (n=16,16) | -0.13 metabolic equivalents (METs) | Standard Deviation 1.57 |
| Eplerenone | 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 | Change at Final Visit (n=111,110) | 0.14 metabolic equivalents (METs) | Standard Deviation 1.56 |
| Placebo | 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 | Change at Month 37 (n=40,33) | 0.68 metabolic equivalents (METs) | Standard Deviation 1.39 |
| Placebo | 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 | Baseline (n=111,110) | 4.89 metabolic equivalents (METs) | Standard Deviation 1.54 |
| Placebo | 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 | Change at Month 25 (n=63,63) | 0.63 metabolic equivalents (METs) | Standard Deviation 1.72 |
| Placebo | 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 | Change at Week 4 (n= 111,108) | 0.27 metabolic equivalents (METs) | Standard Deviation 1.08 |
| Placebo | 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 | Change at Month 48 (n=16,16) | 0.64 metabolic equivalents (METs) | Standard Deviation 1.59 |
| Placebo | 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 | Change at Month 5 (n=104,106) | 0.33 metabolic equivalents (METs) | Standard Deviation 1.19 |
| Placebo | 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 | Change at Month 29 (n=53,48) | 0.65 metabolic equivalents (METs) | Standard Deviation 1.56 |
| Placebo | 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 | Change at Month 9 (n=99,104) | 0.37 metabolic equivalents (METs) | Standard Deviation 1.39 |
| Placebo | 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 | Change at Month 42 (n=30,26) | 0.47 metabolic equivalents (METs) | Standard Deviation 1.83 |
| Placebo | 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 | Change at Month 13 (n=94,102) | 0.44 metabolic equivalents (METs) | Standard Deviation 1.45 |
| Placebo | 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 | Change at Month 33 (n=46,40) | 0.51 metabolic equivalents (METs) | Standard Deviation 1.8 |
| Placebo | 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 | Change at Month 17 (n=81,82) | 0.47 metabolic equivalents (METs) | Standard Deviation 1.81 |
| Placebo | 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 | Change at Final Visit (n=111,110) | 0.25 metabolic equivalents (METs) | Standard Deviation 1.65 |
| Placebo | 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 | Change at Month 21 (n=72,73) | 0.59 metabolic equivalents (METs) | Standard Deviation 1.64 |
Comparison: Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.21, 0.37]
Comparison: Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.34, 0.3]
Comparison: Change from baseline at Month 13: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.27, 0.39]
Comparison: Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.41, 0.45]
Comparison: Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.56, 0.24]
Comparison: Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.55, 0.25]
Comparison: Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.49, 0.31]
Comparison: Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.57, 0.44]
Comparison: Change from baseline at Month 37 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.5, 0.54]
Comparison: Change from baseline at Month 42 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.90% CI: [-0.44, 0.83]
Comparison: Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.63, 0.89]
Comparison: Change from baseline at Week 4 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-0.36, 0.11]
Secondary
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)
Population: Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone | 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 | Change at Final Visit (n=109,110) | -29.30 microgram per gram creatinine (mg/gCr) | Standard Deviation 597.07 |
| Eplerenone | 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 | Baseline (n=111,108) | 169.82 microgram per gram creatinine (mg/gCr) | Standard Deviation 787.32 |
| Eplerenone | 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 | Change at Month 5 (n=104,103) | -21.14 microgram per gram creatinine (mg/gCr) | Standard Deviation 359.53 |
| Eplerenone | 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 | Change at Month 9 (n=98,101) | -11.10 microgram per gram creatinine (mg/gCr) | Standard Deviation 249.68 |
| Eplerenone | 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 | Change at Month 13 (n=94,98) | -41.56 microgram per gram creatinine (mg/gCr) | Standard Deviation 322.12 |
| Eplerenone | 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 | Change at Month 17 (n=80,82) | -13.66 microgram per gram creatinine (mg/gCr) | Standard Deviation 247.48 |
| Eplerenone | 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 | Change at Month 21 (n=72,73) | -63.65 microgram per gram creatinine (mg/gCr) | Standard Deviation 498 |
| Eplerenone | 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 | Change at Month 25 (n=62,63) | 17.17 microgram per gram creatinine (mg/gCr) | Standard Deviation 489.08 |
| Eplerenone | 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 | Change at Month 29 (n=50,47) | 18.51 microgram per gram creatinine (mg/gCr) | Standard Deviation 454.75 |
| Eplerenone | 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 | Change at Month 33 (n=43,39) | -47.07 microgram per gram creatinine (mg/gCr) | Standard Deviation 506.66 |
| Eplerenone | 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 | Change at Month 37 (n=39,33) | -80.21 microgram per gram creatinine (mg/gCr) | Standard Deviation 743.85 |
| Eplerenone | 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 | Change at Month 42 (n=27,25) | -162.18 microgram per gram creatinine (mg/gCr) | Standard Deviation 921.61 |
| Eplerenone | 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 | Change at Month 48 (n=16,16) | -303.19 microgram per gram creatinine (mg/gCr) | Standard Deviation 1211.28 |
| Placebo | 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 | Change at Month 37 (n=39,33) | 34.20 microgram per gram creatinine (mg/gCr) | Standard Deviation 393.95 |
| Placebo | 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 | Change at Month 25 (n=62,63) | 30.08 microgram per gram creatinine (mg/gCr) | Standard Deviation 350.86 |
| Placebo | 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 | Baseline (n=111,108) | 154.93 microgram per gram creatinine (mg/gCr) | Standard Deviation 366.44 |
| Placebo | 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 | Change at Month 48 (n=16,16) | -41.03 microgram per gram creatinine (mg/gCr) | Standard Deviation 113.7 |
| Placebo | 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 | Change at Month 5 (n=104,103) | 46.23 microgram per gram creatinine (mg/gCr) | Standard Deviation 377.56 |
| Placebo | 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 | Change at Month 29 (n=50,47) | -4.58 microgram per gram creatinine (mg/gCr) | Standard Deviation 504.53 |
| Placebo | 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 | Change at Month 9 (n=98,101) | 23.79 microgram per gram creatinine (mg/gCr) | Standard Deviation 362.35 |
| Placebo | 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 | Change at Month 42 (n=27,25) | -29.95 microgram per gram creatinine (mg/gCr) | Standard Deviation 187.19 |
| Placebo | 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 | Change at Month 13 (n=94,98) | -19.04 microgram per gram creatinine (mg/gCr) | Standard Deviation 253.57 |
| Placebo | 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 | Change at Month 33 (n=43,39) | -3.38 microgram per gram creatinine (mg/gCr) | Standard Deviation 417.43 |
| Placebo | 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 | Change at Month 17 (n=80,82) | 79.28 microgram per gram creatinine (mg/gCr) | Standard Deviation 530.74 |
| Placebo | 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 | Change at Final Visit (n=109,110) | -31.56 microgram per gram creatinine (mg/gCr) | Standard Deviation 271.71 |
| Placebo | 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 | Change at Month 21 (n=72,73) | 28.84 microgram per gram creatinine (mg/gCr) | Standard Deviation 431.48 |
Comparison: Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-211.88, 52.63]
Comparison: Change from baseline at Month 5: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-186.44, 63.37]
Comparison: Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-131.27, 81.39]
Comparison: Change from baseline at Month 13 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-97.28, 72.13]
Comparison: Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-221.25, 64.31]
Comparison: Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-230.01, 268.71]
Comparison: Change from baseline at Month 29: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-194.21, 152.11]
Comparison: Change from baseline at Month 33: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-197.55, 115.97]
Comparison: Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-247.11, 158.15]
Comparison: Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.90% CI: [-238.31, 182.93]
Comparison: Change from baseline at Month 48: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-221.17, 158.24]
Comparison: Change from baseline at Month 13 :ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.95% CI: [-58.91, 54.83]
Secondary
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)
Population: Full analysis set included all randomized participants. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eplerenone | 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 | Month 4 (n=106, 106) : Unchanged | 82 participants |
| Eplerenone | 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 | Month 17 (n=81, 82) : Worse | 1 participants |
| Eplerenone | 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 | Month 2 (n=109, 109) : Unchanged | 94 participants |
| Eplerenone | 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 | Month 21 (n=72, 73) : Improved | 21 participants |
| Eplerenone | 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 | Month 4 (n=106, 106) : Worse | 2 participants |
| Eplerenone | 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 | Month 21 (n=72, 73) : Unchanged | 50 participants |
| Eplerenone | 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 | Week 4 (n=111, 108) : Unchanged | 101 participants |
| Eplerenone | 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 | Month 21 (n=72, 73) : Worse | 1 participants |
| Eplerenone | 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 | Month 5 (n=104, 106) : Improved | 24 participants |
| Eplerenone | 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 | Month 25 (n=63, 64) : Improved | 23 participants |
| Eplerenone | 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 | Month 2 (n=109, 109) : Worse | 0 participants |
| Eplerenone | 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 | Month 25 (n=63, 64) : Unchanged | 38 participants |
| Eplerenone | 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 | Month 5 (n=104, 106) : Unchanged | 76 participants |
| Eplerenone | 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 | Month 25 (n=63, 64) : Worse | 2 participants |
| Eplerenone | 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 | Week 1 (n=111, 110) : Unchanged | 107 participants |
| Eplerenone | 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 | Month 29 (n=53, 48) : Improved | 17 participants |
| Eplerenone | 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 | Month 5 (n=104, 106) : Worse | 4 participants |
| Eplerenone | 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 | Month 29 (n=53, 48) : Unchanged | 36 participants |
| Eplerenone | 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 | Month 3 (n=106, 107) : Improved | 18 participants |
| Eplerenone | 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 | Month 29 (n=53, 48) : Worse | 0 participants |
| Eplerenone | 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 | Month 9 (n=99, 105) : Improved | 27 participants |
| Eplerenone | 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 | Month 33 (n=46, 39) : Improved | 14 participants |
| Eplerenone | 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 | Week 4 (n=111, 108) : Worse | 0 participants |
| Eplerenone | 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 | Month 33 (n=46, 39) : Unchanged | 31 participants |
| Eplerenone | 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 | Month 9 (n=99, 105) : Unchanged | 71 participants |
| Eplerenone | 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 | Month 33 (n=46, 39) : Worse | 1 participants |
| Eplerenone | 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 | Month 3 (n=106, 107) : Unchanged | 88 participants |
| Eplerenone | 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 | Month 37 (n=40, 33) : Improved | 12 participants |
| Eplerenone | 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 | Month 9 (n=99, 105) : Worse | 1 participants |
| Eplerenone | 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 | Month 37 (n=40, 33) : Unchanged | 28 participants |
| Eplerenone | 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 | Week 4 (n=111, 108) : Improved | 10 participants |
| Eplerenone | 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 | Month 37 (n=40, 33) : Worse | 0 participants |
| Eplerenone | 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 | Month 13 (n=94, 102) : Improved | 31 participants |
| Eplerenone | 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 | Month 42 (n=30, 26) : Improved | 7 participants |
| Eplerenone | 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 | Month 3 (n=106, 107) : Worse | 0 participants |
| Eplerenone | 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 | Month 42 (n=30, 26) : Unchanged | 23 participants |
| Eplerenone | 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 | Month 13 (n=94, 102) : Unchanged | 62 participants |
| Eplerenone | 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 | Month 42 (n=30, 26) : Worse | 0 participants |
| Eplerenone | 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 | Month 2 (n=109, 109) : Improved | 15 participants |
| Eplerenone | 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 | Month 48 (n=16, 16) : Improved | 2 participants |
| Eplerenone | 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 | Month 13 (n=94, 102) : Worse | 1 participants |
| Eplerenone | 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 | Month 48 (n=16, 16) : Unchanged | 14 participants |
| Eplerenone | 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 | Month 4 (n=106, 106) : Improved | 22 participants |
| Eplerenone | 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 | Month 48 (n=16, 16) : Worse | 0 participants |
| Eplerenone | 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 | Month 17 (n=81, 82) : Improved | 25 participants |
| Eplerenone | 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 | Final Visit (n=111, 110) : Improved | 25 participants |
| Eplerenone | 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 | Week 1 (n=111, 110) : Worse | 0 participants |
| Eplerenone | 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 | Final Visit (n=111, 110) : Unchanged | 80 participants |
| Eplerenone | 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 | Month 17 (n=81, 82) : Unchanged | 55 participants |
| Eplerenone | 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 | Final Visit (n=111, 110) : Worse | 6 participants |
| Eplerenone | 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 | Week 1 (n=111, 110) : Improved | 4 participants |
| Placebo | 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 | Final Visit (n=111, 110) : Worse | 4 participants |
| Placebo | 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 | Week 1 (n=111, 110) : Improved | 2 participants |
| Placebo | 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 | Week 1 (n=111, 110) : Unchanged | 107 participants |
| Placebo | 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 | Week 1 (n=111, 110) : Worse | 1 participants |
| Placebo | 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 | Week 4 (n=111, 108) : Improved | 14 participants |
| Placebo | 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 | Week 4 (n=111, 108) : Unchanged | 92 participants |
| Placebo | 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 | Week 4 (n=111, 108) : Worse | 2 participants |
| Placebo | 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 | Month 2 (n=109, 109) : Improved | 14 participants |
| Placebo | 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 | Month 2 (n=109, 109) : Unchanged | 95 participants |
| Placebo | 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 | Month 2 (n=109, 109) : Worse | 0 participants |
| Placebo | 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 | Month 3 (n=106, 107) : Improved | 16 participants |
| Placebo | 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 | Month 3 (n=106, 107) : Unchanged | 91 participants |
| Placebo | 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 | Month 3 (n=106, 107) : Worse | 0 participants |
| Placebo | 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 | Month 4 (n=106, 106) : Improved | 20 participants |
| Placebo | 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 | Month 4 (n=106, 106) : Unchanged | 86 participants |
| Placebo | 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 | Month 4 (n=106, 106) : Worse | 0 participants |
| Placebo | 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 | Month 5 (n=104, 106) : Improved | 22 participants |
| Placebo | 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 | Month 5 (n=104, 106) : Unchanged | 83 participants |
| Placebo | 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 | Month 5 (n=104, 106) : Worse | 1 participants |
| Placebo | 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 | Month 9 (n=99, 105) : Improved | 20 participants |
| Placebo | 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 | Month 9 (n=99, 105) : Unchanged | 81 participants |
| Placebo | 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 | Month 9 (n=99, 105) : Worse | 4 participants |
| Placebo | 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 | Month 13 (n=94, 102) : Improved | 19 participants |
| Placebo | 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 | Month 13 (n=94, 102) : Unchanged | 82 participants |
| Placebo | 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 | Month 13 (n=94, 102) : Worse | 1 participants |
| Placebo | 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 | Month 17 (n=81, 82) : Improved | 18 participants |
| Placebo | 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 | Month 17 (n=81, 82) : Unchanged | 61 participants |
| Placebo | 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 | Month 17 (n=81, 82) : Worse | 3 participants |
| Placebo | 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 | Month 21 (n=72, 73) : Improved | 19 participants |
| Placebo | 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 | Month 21 (n=72, 73) : Unchanged | 51 participants |
| Placebo | 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 | Month 21 (n=72, 73) : Worse | 3 participants |
| Placebo | 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 | Month 25 (n=63, 64) : Improved | 14 participants |
| Placebo | 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 | Month 25 (n=63, 64) : Unchanged | 48 participants |
| Placebo | 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 | Month 25 (n=63, 64) : Worse | 2 participants |
| Placebo | 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 | Month 29 (n=53, 48) : Improved | 12 participants |
| Placebo | 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 | Month 29 (n=53, 48) : Unchanged | 35 participants |
| Placebo | 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 | Month 29 (n=53, 48) : Worse | 1 participants |
| Placebo | 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 | Month 33 (n=46, 39) : Improved | 10 participants |
| Placebo | 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 | Month 33 (n=46, 39) : Unchanged | 27 participants |
| Placebo | 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 | Month 33 (n=46, 39) : Worse | 2 participants |
| Placebo | 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 | Month 37 (n=40, 33) : Improved | 10 participants |
| Placebo | 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 | Month 37 (n=40, 33) : Unchanged | 22 participants |
| Placebo | 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 | Month 37 (n=40, 33) : Worse | 1 participants |
| Placebo | 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 | Month 42 (n=30, 26) : Improved | 7 participants |
| Placebo | 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 | Month 42 (n=30, 26) : Unchanged | 18 participants |
| Placebo | 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 | Month 42 (n=30, 26) : Worse | 1 participants |
| Placebo | 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 | Month 48 (n=16, 16) : Improved | 6 participants |
| Placebo | 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 | Month 48 (n=16, 16) : Unchanged | 9 participants |
| Placebo | 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 | Month 48 (n=16, 16) : Worse | 1 participants |
| Placebo | 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 | Final Visit (n=111, 110) : Improved | 26 participants |
| Placebo | 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 | Final Visit (n=111, 110) : Unchanged | 80 participants |
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening | 38 participants |
| Placebo | Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening | 43 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.53, 1.28]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of All-cause Hospitalization | 45 participants |
| Placebo | Number of Participants With First Occurrence of All-cause Hospitalization | 58 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.44, 0.97]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization | 48 participants |
| Placebo | Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization | 61 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.45, 0.97]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization | 35 participants |
| Placebo | Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization | 44 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.45, 1.1]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication | 42 participants |
| Placebo | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication | 45 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.56, 1.31]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI) | 1 participants |
| Placebo | Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI) | 1 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.07, 17.85]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke | 3 participants |
| Placebo | Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke | 4 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.18, 3.53]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization | 29 participants |
| Placebo | Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization | 33 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>=-50 ml/min/1.73 m\^2) covariates.95% CI: [0.49, 1.33]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function | 2 participants |
| Placebo | Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function | 2 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.16, 8.04]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF) | 27 participants |
| Placebo | Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF) | 33 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.45, 1.25]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of Hospitalization for Hyperkalemia | 0 participants |
| Placebo | Number of Participants With First Occurrence of Hospitalization for Hyperkalemia | 0 participants |
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter | 4 participants |
| Placebo | Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter | 2 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.39, 11.56]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With First Occurrence of New Onset Diabetes Mellitus | 1 participants |
| Placebo | Number of Participants With First Occurrence of New Onset Diabetes Mellitus | 2 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.05, 5.66]
Secondary
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.
Time frame: Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eplerenone | Number of Participants With With First Occurrence of All-Cause Mortality | During treatment | 6 participants |
| Eplerenone | Number of Participants With With First Occurrence of All-Cause Mortality | Within 30 days of treatment discontinuation | 1 participants |
| Eplerenone | Number of Participants With With First Occurrence of All-Cause Mortality | After 30 days of treatment discontinuation | 10 participants |
| Placebo | Number of Participants With With First Occurrence of All-Cause Mortality | During treatment | 5 participants |
| Placebo | Number of Participants With With First Occurrence of All-Cause Mortality | Within 30 days of treatment discontinuation | 1 participants |
| Placebo | Number of Participants With With First Occurrence of All-Cause Mortality | After 30 days of treatment discontinuation | 4 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.81, 3.87]
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With With First Occurrence of Cardiovascular Mortality | 14 participants |
| Placebo | Number of Participants With With First Occurrence of Cardiovascular Mortality | 6 participants |
Comparison: Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.95% CI: [0.92, 6.24]