The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)
Chronic Heart Failure
About this trial
This is an interventional treatment trial for Chronic Heart Failure
Eligibility 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.
- Primary disease: In principle, ischemic heart disease or dilated cardiomyopathy.
- Heart failure patients with 40% or less of left ventricular ejection fraction (LVEF) .
- Patients in NYHA functional classification Class II, III, or IV (including a medical history).
- Basic treatment: In principle, patients undergoing treatment with an ACE inhibitor (or angiotensin receptor blocker (ARB)), a diuretic, a digitalis preparation, etc.
- Patients who had not undergone treatment with a beta-blocker (except eye drops) within 8 weeks before the registration date.
- Age: Patients aged 20 to less than 85 on the day of obtaining written informed consent.
- Hospitalized/outpatient: Either hospitalized or outpatient status.
- Gender: Male or Female
Exclusion Criteria:
Patients who meet any of the following exclusion criteria at the time of registration will be excluded:
- Patients who are considered not to be candidates for administration of bisoprolol or carvedilol.
- Patients who have developed acute myocardial infarction within 8 weeks before the registration day.
- Patients who have history of stroke or serious cerebrovascular accident within 1 year before the registration day.
- Patients with poor prognosis and life-threatening disease, such as malignant tumor, or such medical history within 5 years before the registration day.
- Patients who are scheduled to undergo coronary revascularization (Coronary artery bypass grafting; CABG, Percutaneous coronary intervention; PCI) during the study period.
- Patients who are pregnant, lactating, may become pregnant, or want to become pregnant during the study.
- Patients from whom written informed consent cannot be obtained.
- Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Sites / Locations
- Banbuntane Hotokukai HospitalRecruiting
- Chukyo HospitalRecruiting
- Nagoya City University HospitalRecruiting
- Takezawa ClinicRecruiting
- Hirosaki University School of Medicine & HospitalRecruiting
- Ehime Prefectural Central HospitalRecruiting
- Saiseikai Matsuyama HospitalRecruiting
- Ehime University HospitalRecruiting
- University of Fukui HospitalRecruiting
- Chiyo ClinicRecruiting
- Kitakyushu Municipal Yahata HospitalRecruiting
- Takagi HospitalRecruiting
- Kizawa memorial hospitalRecruiting
- Gunma University HospitalRecruiting
- Gunmaken Saiseikai Maebashi HospitalRecruiting
- Maebashi Red Cross HospitalRecruiting
- Ota Memorial HospitalRecruiting
- National Hospital Organization Kure Medical CenterRecruiting
- Shobara Red Cross HospitalRecruiting
- Hokkaido P.W.F.A.C Asahikawa-Kosei General HospitalRecruiting
- Kihara cardiovascular clinicRecruiting
- Ebetsu City HospitalRecruiting
- Hokkaido Chuo Rosai HospitalRecruiting
- Otaru Kyokai HospitalRecruiting
- Hokkaido Medical CenterRecruiting
- JR Sapporo HospitalRecruiting
- KKR Sapporo Medical CenterRecruiting
- Sapporo City General HospitalRecruiting
- Sapporo Medical Center NTT EastRecruiting
- Sapporo Medical University HospitalRecruiting
- Sunagawa City Medical CenterRecruiting
- Hyogo Brain and Heart CenterRecruiting
- Kobe University HospitalRecruiting
- Hyogo College Of MedicineRecruiting
- Nishiwaki Municipal HospitalRecruiting
- Hitachi General HospitalRecruiting
- Kanazawa Cardiovascular HospitalRecruiting
- Kanazawa University HospitalRecruiting
- Kagawa UniversityRecruiting
- St. Marianna University School of MedicineRecruiting
- Kitasato University HospitalRecruiting
- Nishi Yokohama HospitalRecruiting
- Yokohamashintoshi Neurosurgical HospitalRecruiting
- Kochi Medical School HospitalRecruiting
- Tohoku University HospitalRecruiting
- Nagasaki Goto Chuoh HospitalRecruiting
- Nara Hospital Kinki University Faculty of MedicineRecruiting
- Nara Prefecture Western Medical CenterRecruiting
- Nara Medical UniversityRecruiting
- Tsunan Metropolitan HospitalRecruiting
- Ohama Daiichi HospitalRecruiting
- Urasoe General HospitalRecruiting
- Osaka National HospitalRecruiting
- Nozaki Tokushukai HospitalRecruiting
- Kansai Medical University Hirakata HospitalRecruiting
- National Cerebral and Cardiovascular CenterRecruiting
- Osaka University HospitalRecruiting
- Yayoigaoka Kage HospitalRecruiting
- Saitama Medical University International Medical CenterRecruiting
- Ikebukuro HospitalRecruiting
- Kusatsu General HospitalRecruiting
- Hamamatsu University HospitalRecruiting
- Juntendo Shizuoka HospitalRecruiting
- Dokkyo Medical UniversityRecruiting
- Ohta ClinicRecruiting
- Nishiarai Heart Center HospitalRecruiting
- Juntendo University HospitalRecruiting
- Medical Hospital of Tokyo Medical and Dental UniversityRecruiting
- Tokyo Metropolitan Tama Medical CenterRecruiting
- Minamino Heart ClinicRecruiting
- Hino Municipal HospitalRecruiting
- Tokyo Medical CenterRecruiting
- 100Recruiting
- Daisankitashinagawa hospitalRecruiting
- Tokyo Medical University HospitalRecruiting
- Tottori University HospitalRecruiting
- Yamaguchi Grand Medical CenterRecruiting
- Shimonoseki City HospitalRecruiting
- Yamaguchi University HospitalRecruiting
- Yamanashi Prefectural Central HospitalRecruiting
- Akita University HospitalRecruiting
- Hakujyuji HospitalRecruiting
- Haradoi HospitalRecruiting
- Kyushu University HospitalRecruiting
- Saiseikai Fukuoka General HospitalRecruiting
- Fukushima Daiichi HospitalRecruiting
- Ohara General HospitalRecruiting
- Gifu University HospitalRecruiting
- Hiroshima General Hospital of West Japan Railway CompanyRecruiting
- Hiroshima University HospitalRecruiting
- Tenyoukai Central HospitalRecruiting
- Kumamoto University HospitalRecruiting
- Kyoto University HospitalRecruiting
- Takenaka ClinicRecruiting
- Ebisu-hospitalRecruiting
- Medical Inc. Kosei-kai Nijigaoka HospitalRecruiting
- Nagasaki University HospitalRecruiting
- Nara City HospitalRecruiting
- Nara Prefecture General Medical CenterRecruiting
- Kuwana hospitalRecruiting
- Niigata University Medical & Dental HospitalRecruiting
- Okayama University HospitalRecruiting
- Graduate School of Medicine and Faculty of MedicineRecruiting
- JCHO Osaka HospitalRecruiting
- Kitano HospitalRecruiting
- Sakurabashi Watanabe HospitalRecruiting
- Saitama Medical Center Jichi Medical UniversityRecruiting
- Tokushima University HospitalRecruiting
- Wakayama Medical University HospitalRecruiting
- Kanoiwa General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Bisoprolol group
Carvedilol 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 (bisoprolol 0.625 mg, 2 tablets; 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).
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 investigator after administering 2.5 mg/day of carvedilol, the dose should be increased to 5 mg (carvedilol 2.5 mg, 1 tablet twice daily) (Step 2). In the same manner, the dose should be increased to 10 mg (carvedilol 2.5 mg, 2 tablets twice daily, Step 3), to 15 mg (carvedilol 2.5 mg, 3 tablets twice daily, Step 4), and to 20 mg (carvedilol 10 mg, 1 tablet twice daily, Step 5).