A clinical study to evaluate efficacy of eplerenone, a new drug for the treatment of acute heart failure while protecting myocardium (a randomized, double-blind, placebo-controlled study)
- Conditions
- acute heart failure
- Registration Number
- JPRN-jRCT2091220127
- Lead Sponsor
- Masafumi Kitakaze
- Brief Summary
The EARLIER study, comparing the efficacy of eplerenone with placebo in the treatment of acute heart failure, failed to achieve the predetermined criterion for consistency with the EPHESUS trial. However, the hazard ratio (95% CI) of "re-hospitalization due to heart failure and cardiovascular death" or "re-hospitalization due to heart failure" within 6 months in the eplerenone group was 0.55 (0.213, 1.434), suggesting that eplerenone prevents re-hospitalization due to heart failure. Moreover, plasma BNP, left ventricular ejection fraction, left ventricular end-diastolic dimension, left ventricular end-systolic dimension and E/e' numerically improved in the eplerenone group compared with the placebo. The safety of eplerenone in patients with AHF was validated in the EARLIER study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
1. Evidence of an informed consent document personally signed and dated by the patient
2. Japanese men and women whose age is 20 years or older at the time of giving the consent;
3. Patients with clinical evidence of acute heart failure, at no earlier than the date of visit and within 3 days of enrollment, demonstrated by at least one of the following ([1] De novo acute heart failure, [2] Acute exacerbation of chronic heart failure, [3] Post-AMI heart failure applicable to [1])
4. Patients whose left ventricular ejection fraction (LVEF) is 40% or less, at no earlier than the date of visit and within 72 hours of enrollment
5. Study subjects who are women must;
(i) Be tested negative for serum or urine pregnancy test prior to randomization (except for women who have undergone panhysterectomy, or are 66 years or older, or have had menopause in the past 24 months or longer); and
(ii) Provide consent to use effective contraceptive method during the study, if the women are of childbearing potential.
1. Patients who had in the past received aldosterone antagonist therapy consecutively for 7 days or longer and who are applicable to the following criteria:
(i) Patients who developed a clinically significant hyperkalemia or renal dysfunction at an early stage of such aldosterone antagonist therapy; and
(ii) Patients who discontinued such aldosterone antagonist therapy no later than 3 months prior to randomization.
2. Patients who have in the past received aldosterone antagonist therapy for less than 7 days, and have received the drug within 48 hours prior to randomization.
3. Patients who have uncontrollable hypertension as defined as SBP > 180 mmHg, or DBP > 110 mmHg.
4. Patients with symptomatic hypotension, or whose SBP immediately prior to enrollment is less than 90 mmHg.
5. Patients who are in the state of cardiogenic shock.
6. Patients with heart failure to which a primary cause is pericardial disease, obstructive cardiomyopathy or restrictive cardiomyopathy, or a surgically-operable valvular disease; provided that patients with heart failure to which a primary cause is a surgically-inoperable valvular disease may be enrolled in this study.
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of combined end point (cardiac death or first re-hospitalization due to cardiac disease) within 6 months from the enrollment
- Secondary Outcome Measures
Name Time Method 1) Incidence of combined end point (cardiac death or first re-hospitalization due to cardiac disease) (within 1 month from the enrollment)