The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)
- Registration Number
- NCT02137733
- Lead Sponsor
- Mebix Inc
- Brief Summary
The purpose of this study is to investigate the non-inferiority of bisoprolol to carvedilol by evaluating tolerability (The probability that administered maintenance dose reaches the maximum will be determined as an indicator) as a primary endpoint when bisoprolol or carvedilol is administered for 48 weeks to Japanese chronic heart failure patients. In addition, the safety and efficacy of bisoprolol will be investigated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 220
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bisoprolol group Bisoprolol 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). Carvedilol group Carvedilol 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).
- Primary Outcome Measures
Name Time Method Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day) 48 weeks
- Secondary Outcome Measures
Name Time Method Efficacy: New York Heart Association (NYHA) Functional Classification 24 and 48 weeks Efficacy: Left Ventricular Ejection Fraction (LVEF) 24 and 48 weeks Efficacy: Heart rate 24 and 48 weeks Efficacy: Plasma brain natriuretic peptide (BNP) 24 and 48 weeks Safety: Deaths with cardiovascular causes 48 weeks Efficacy: Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV) 24 and 48 weeks Safety: All deaths 48 weeks Safety: Hospitalization for cardiovascular causes 48 weeks Safety: Exacerbation of heart failure, resulting in hospitalization, and/or intensification of treatment (increase in dose of any diuretics, vasodilators or cardiotonics, in comparison with the dose-setting period), or administration of new drugs. 48 weeks Safety: Deaths due to heart failure (pump-failure deaths, and deaths associated with exacerbation of heart failure) 48 weeks Safety: Sudden deaths, including deaths due to arrhythmia 48 weeks Safety: Deaths with non-cardiovascular causes 48 weeks Safety: Adverse events 48 weeks Safety: Changes in clinical laboratory test results 48 weeks
Trial Locations
- Locations (110)
Chukyo Hospital
🇯🇵Nagoya, Aichi, Japan
Takezawa Clinic
🇯🇵Nagoya, Aichi, Japan
St. Marianna University School of Medicine
🇯🇵Kawasaki, Kanagawa, Japan
Saiseikai Matsuyama Hospital
🇯🇵Matsuyama, Ehime, Japan
KKR Sapporo Medical Center
🇯🇵Sapporo, Hokkaido, Japan
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
Ota Memorial Hospital
🇯🇵Fukuyama, Hiroshima, Japan
Hitachi General Hospital
🇯🇵Hitachi, Ibaraki, Japan
Kochi Medical School Hospital
🇯🇵Nankoku, Kochi, Japan
Nara Hospital Kinki University Faculty of Medicine
🇯🇵Ikoma, Nara, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
Ikebukuro Hospital
🇯🇵Kawagoe, Saitama, Japan
Dokkyo Medical University
🇯🇵Shimotsuga-gun, Tochigi, Japan
Ohta Clinic
🇯🇵Anan, Tokushima, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Hino Municipal Hospital
🇯🇵Hino, Tokyo, Japan
Yamaguchi University Hospital
🇯🇵Ube, Yamaguchi, Japan
Tottori University Hospital
🇯🇵Yonago, Tottori, Japan
Daisankitashinagawa hospital
🇯🇵Shinagawa-ku, Tokyo, Japan
Nara Prefecture General Medical Center
🇯🇵Nara, Japan
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Graduate School of Medicine and Faculty of Medicine
🇯🇵Osaka, Japan
JCHO Osaka Hospital
🇯🇵Osaka, Japan
Sakurabashi Watanabe Hospital
🇯🇵Osaka, Japan
Saitama Medical Center Jichi Medical University
🇯🇵Saitama, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Japan
Banbuntane Hotokukai Hospital
🇯🇵Nagoya, Aichi, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama, Ehime, Japan
Hirosaki University School of Medicine & Hospital
🇯🇵Hirosaki, Aomori, Japan
Ehime University Hospital
🇯🇵Toon, Ehime, Japan
University of Fukui Hospital
🇯🇵Yoshida-gun, Fukui, Japan
Chiyo Clinic
🇯🇵Kitakyushu, Fukuoka, Japan
Kizawa memorial hospital
🇯🇵Minokamo, Gifu, Japan
Kitakyushu Municipal Yahata Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Takagi Hospital
🇯🇵Okawa, Fukuoka, Japan
Gunmaken Saiseikai Maebashi Hospital
🇯🇵Maebashi, Gunma, Japan
Maebashi Red Cross Hospital
🇯🇵Maebashi, Gunma, Japan
National Hospital Organization Kure Medical Center
🇯🇵Kure, Hiroshima, Japan
Shobara Red Cross Hospital
🇯🇵Shobara, Hiroshima, Japan
Kihara cardiovascular clinic
🇯🇵Asahikawa, Hokkaido, Japan
Hokkaido P.W.F.A.C Asahikawa-Kosei General Hospital
🇯🇵Asahikawa, Hokkaido, Japan
Ebetsu City Hospital
🇯🇵Ebetsu, Hokkaido, Japan
Hokkaido Chuo Rosai Hospital
🇯🇵Iwami, Hokkaido, Japan
Otaru Kyokai Hospital
🇯🇵Otaru, Hokkaido, Japan
Hokkaido Medical Center
🇯🇵Sapporo, Hokkaido, Japan
JR Sapporo Hospital
🇯🇵Sapporo, Hokkaido, Japan
Sapporo City General Hospital
🇯🇵Sapporo, Hokkaido, Japan
Sapporo Medical Center NTT East
🇯🇵Sapporo, Hokkaido, Japan
Sunagawa City Medical Center
🇯🇵Sunagawa, Hokkaido, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kobe University Hospital
🇯🇵Kobe, Hyogo, Japan
Hyogo Brain and Heart Center
🇯🇵Himeji, Hyogo, Japan
Hyogo College Of Medicine
🇯🇵Nishinomiya, Hyogo, Japan
Kagawa University
🇯🇵Kita-gun, Kagawa, Japan
Nishiwaki Municipal Hospital
🇯🇵Nishiwaki, Hyogo, Japan
Kanazawa Cardiovascular Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Nishi Yokohama Hospital
🇯🇵Yokohama, Kanagawa, Japan
Kanazawa University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Kitasato University Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Yokohamashintoshi Neurosurgical Hospital
🇯🇵Yokohama, Kanagawa, Japan
Tohoku University Hospital
🇯🇵Sendai, Miyagi, Japan
Nagasaki Goto Chuoh Hospital
🇯🇵Goto, Nagasaki, Japan
Nara Prefecture Western Medical Center
🇯🇵Ikoma, Nara, Japan
Tsunan Metropolitan Hospital
🇯🇵Nakauonuma-gun, Niigata, Japan
Ohama Daiichi Hospital
🇯🇵Naha, Okinawa, Japan
Nara Medical University
🇯🇵Kashihara, Nara, Japan
Nozaki Tokushukai Hospital
🇯🇵Daito, Osaka, Japan
Urasoe General Hospital
🇯🇵Urasoe, Okinawa, Japan
Osaka National Hospital
🇯🇵Chuo, Osaka, Japan
Kansai Medical University Hirakata Hospital
🇯🇵Hirakata, Osaka, Japan
National Cerebral and Cardiovascular Center
🇯🇵Suita, Osaka, Japan
Yayoigaoka Kage Hospital
🇯🇵Tosu, Saga, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Kusatsu General Hospital
🇯🇵Kusatsu, Shiga, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Juntendo Shizuoka Hospital
🇯🇵Izunokuni, Shizuoka, Japan
Nishiarai Heart Center Hospital
🇯🇵Adachi-ku, Tokyo, Japan
Medical Hospital of Tokyo Medical and Dental University
🇯🇵Bunkyo-ku, Tokyo, Japan
Minamino Heart Clinic
🇯🇵Hachioji, Tokyo, Japan
Tokyo Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Tokyo Metropolitan Tama Medical Center
🇯🇵Fuchu, Tokyo, Japan
100
🇯🇵Setagaya-ku, Tokyo, Japan
Yamaguchi Grand Medical Center
🇯🇵Hofu, Yamaguchi, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Shimonoseki City Hospital
🇯🇵Shimonoseki, Yamaguchi, Japan
Yamanashi Prefectural Central Hospital
🇯🇵Kofu, Yamanashi, Japan
Akita University Hospital
🇯🇵Akita, Japan
Hakujyuji Hospital
🇯🇵Fukuoka, Japan
Haradoi Hospital
🇯🇵Fukuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Saiseikai Fukuoka General Hospital
🇯🇵Fukuoka, Japan
Fukushima Daiichi Hospital
🇯🇵Fukushima, Japan
Ohara General Hospital
🇯🇵Fukushima, Japan
Gifu University Hospital
🇯🇵Gifu, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Hiroshima General Hospital of West Japan Railway Company
🇯🇵Hiroshima, Japan
Tenyoukai Central Hospital
🇯🇵Kagoshima, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
Ebisu-hospital
🇯🇵Nagasaki, Japan
Takenaka Clinic
🇯🇵Kyoto, Japan
Medical Inc. Kosei-kai Nijigaoka Hospital
🇯🇵Nagasaki, Japan
Nara City Hospital
🇯🇵Nara, Japan
Kuwana hospital
🇯🇵Niigata, Japan
Kitano Hospital
🇯🇵Osaka, Japan
Tokushima University Hospital
🇯🇵Tokushima, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama, Japan
Kanoiwa General Hospital
🇯🇵Yamanashi, Japan