Chronic heart failure
Conditions
Interventions
Bisoprolol group Daily oral administration of bisoprolol 0.625 mg tablet once a day should be given (Step 1). If tolerability is confirmed by an investigator, the dose should be increased to 1.25 mg
or bisoprolol 2.5 mg, half tablet
once daily) (Step 2). In the same manner, the doses should be increased to 2.5 mg (bisoprolol 2.5 mg, 1 tablet
or bisoprolol 5 mg, half tablet
once daily, Step 3), to 3.75 mg (bisoprolol 2.5 mg, 1.5 tablets once daily, Step 4), and to 5 mg (bisoprolol 2.5 mg, 2 tablets
or bisoprolol 5 mg, 1 tablet
once daily, Step 5).
Carvedilol group Daily oral administration of carvedilol 1.25 mg, 1 tablet twice a day (after breakfast and supper) should be given (Step 1). If tolerability is confirmed by an i
Sponsors
CIBIS-J study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: As a result of diagnosis and tests before registration, a patient who is considered by an investigator to meet all requirements and to have ability to consent can be enrolled. (1) Primary disease: In principle, ischemic heart disease or dilated cardiomyopathy. (2) Heart failure patients with 40% or less of left ventricular ejection fraction (LVEF). (3) Patients in NYHA functional classification Class II, III, or IV (including a medical history). (4) Basic treatment: In principle, patients undergoing treatment with an ACE inhibitor (or angiotensin receptor blocker (ARB)), a diuretic, a digitalis preparation, etc. (5) Patients who had not undergone treatment with a beta-blocker (except eye drops) within 8 weeks before the registration date. (6) Age: Patients aged 20 to less than 85 on the day of obtaining written informed consent. (7) Hospitalized/outpatient: Either hospitalized or outpatient status. (8) Gender: Male or Female
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria at the time of registration will be excluded: (1) Patients who are considered not to be candidates for administration of bisoprolol or carvedilol. (2) Patients who have developed acute myocardial infarction within 8 weeks before the registration day. (3) Patients who have history of stroke or serious cerebrovascular accident within 1 year before the registration day. (4) Patients with poor prognosis and life-threatening disease, such as malignant tumor, or such medical history within 5 years before the registration day. (5) Patients who are scheduled to undergo coronary revascularization (CABG, PCI) during the study period. (6) Patients who are pregnant, lactating, may become pregnant, or want to become pregnant during the study. (7) Patients from whom written informed consent cannot be obtained. (8) Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day) | — |
Countries
Japan
Contacts
Public ContactMakoto Arai
Mebix, Inc. CIBIS-J Research Operations Office
Outcome results
None listed