NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00127

Registered date:03/06/2013

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)

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studiedacute heart failure
Date of first enrollment21/06/2013
Target sample size300
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:DRUG. Intervention1:SC-66110, Dose form:TABLET, Route of administration:ORAL. Control intervention1:placebo, Dose form:TABLET, Route of administration:ORAL.

Outcome(s)

Primary OutcomeIncidence of combined end point (cardiac death or first re-hospitalization due to cardiac disease) within 6 months from the enrollment. Timepoint:6 months.
Secondary Outcome1) Incidence of combined end point (cardiac death or first re-hospitalization due to cardiac disease) (within 1 month from the enrollment). Timepoint: 6 months.

Key inclusion & exclusion criteria

Age minimum>=20 YEARS
Age maximumNo Limit
GenderBOTH
Include criteria1. 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.
Exclude criteria1. 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.

Related Information

Contact

public contact
Name Atsuko Yokoe
Address Earlier clinical trial office,5-7-1 Fujishirodai Suita Osaka
Telephone +81-6-6833-5012
E-mail EARLIER.chiken.ccc01@gmail.com
Affiliation Earlier clinical trial office
scientific contact
Name Masafumi Kitakaze
Address Department of clinical research,6-1 Kishibe-Shimmach, Suita, Osaka
Telephone +81-6-6170-1070
E-mail
Affiliation National Cerebral and Cardiovascular Center