Phase 3
Completed N=221
Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure
Source: ClinicalTrials.gov NCT01115855 ↗Enrolled (actual)
221
Serious AEs
52.9%
Results posted
Oct 2016
Primary outcomePrimary: Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) — 33; 36 participants
◆ Published Evidence
Established
38citations · ~4 / year
Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Eplerenone in Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF).
Summary
A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure patients with placebo.
Linked Publications
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Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Eplerenone in Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) |
33; 36 | — |
| 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 |
42; 45 | — |
| SECONDARY Number of Participants With With First Occurrence of All-Cause Mortality |
6; 5; 1; 1; 10; 4 | — |
| SECONDARY Number of Participants With With First Occurrence of Cardiovascular Mortality |
14; 6 | — |
| SECONDARY Number of Participants With First Occurrence of All-cause Hospitalization |
45; 58 | — |
| SECONDARY Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF) |
27; 33 | — |
| SECONDARY Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization |
48; 61 | — |
| SECONDARY Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization |
29; 33 | — |
| SECONDARY Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization |
35; 44 | — |
| SECONDARY Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening |
38; 43 | — |
| SECONDARY Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke |
3; 4 | — |
| SECONDARY Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI) |
1; 1 | — |
| SECONDARY Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter |
4; 2 | — |
| SECONDARY Number of Participants With First Occurrence of New Onset Diabetes Mellitus |
1; 2 | — |
| SECONDARY Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function |
2; 2 | — |
| SECONDARY Number of Participants With First Occurrence of Hospitalization for Hyperkalemia |
0; 0 | — |
| 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 |
469.29; 435.61; -169.75; -36.36; -208.54; -76.23 | — |
| 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 |
2635.78; 2354.31; -770.51; -205.18; -884.76; -425.47 | — |
| 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 |
25.64; 26.64; 5.98; 4.01; 33.89; 31.37 | — |
| 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 |
169.82; 154.93; -21.14; 46.23; -11.10; 23.79 | — |
| 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 |
4; 2; 107; 107; 0; 1 | — |
| 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 |
4.85; 4.89; 0.15; 0.27; 0.46; 0.33 | — |
Eligibility Criteria
Inclusion Criteria
- Japanese chronic systolic heart failure patients with LVEF = 5.0 mmol/L or eGFR <30 ml/min/1.73 m2.
Data sourced from ClinicalTrials.gov (NCT01115855) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.