acute heart failure
Conditions
Interventions
Intervention type:DRUG
Name of intervention:SC-66110
Dose form / Japanese Medical Device Nomenclature:TABLET
Route of administration / Site of application:ORAL
Dose per administration:50mg
mg
Dosing f
Sponsors
Masafumi Kitakaze
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of combined end point (cardiac death or first re-hospitalization due to cardiac disease) within 6 months from the enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence of combined end point (cardiac death or first re-hospitalization due to cardiac disease) (within 1 month from the enrollment) | — |
Countries
Japan
Contacts
Public ContactAtsuko Yokoe
Earlier clinical trial office
Outcome results
None listed