The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)
1 other identifier
interventional
220
1 country
110
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedMay 14, 2014
May 1, 2014
2.9 years
May 1, 2014
May 10, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day)
48 weeks
Secondary Outcomes (14)
Efficacy: New York Heart Association (NYHA) Functional Classification
24 and 48 weeks
Efficacy: Left Ventricular Ejection Fraction (LVEF)
24 and 48 weeks
Efficacy: Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV)
24 and 48 weeks
Efficacy: Heart rate
24 and 48 weeks
Efficacy: Plasma brain natriuretic peptide (BNP)
24 and 48 weeks
- +9 more secondary outcomes
Study Arms (2)
Bisoprolol group
ACTIVE COMPARATORDaily 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
ACTIVE COMPARATORDaily 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mebix Inclead
Study Sites (110)
Banbuntane Hotokukai Hospital
Nagoya, Aichi-ken, Japan
Chukyo Hospital
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Takezawa Clinic
Nagoya, Aichi-ken, Japan
Akita University Hospital
Akita, Akita, Japan
Hirosaki University School of Medicine & Hospital
Hirosaki, Aomori, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, Japan
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, Japan
Ehime University Hospital
Tōon, Ehime, Japan
University of Fukui Hospital
Yoshida-gun, Fukui, Japan
Hakujyuji Hospital
Fukuoka, Fukuoka, Japan
Haradoi Hospital
Fukuoka, Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka, Japan
Chiyo Clinic
Kitakyushu, Fukuoka, Japan
Kitakyushu Municipal Yahata Hospital
Kitakyushu, Fukuoka, Japan
Takagi Hospital
Ōkawa, Fukuoka, Japan
Fukushima Daiichi Hospital
Fukushima, Fukushima, Japan
Ohara General Hospital
Fukushima, Fukushima, Japan
Gifu University Hospital
Gifu, Gifu, Japan
Kizawa memorial hospital
Minokamo, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Gunmaken Saiseikai Maebashi Hospital
Maebashi, Gunma, Japan
Maebashi Red Cross Hospital
Maebashi, Gunma, Japan
Ota Memorial Hospital
Fukuyama, Hiroshima, Japan
Hiroshima General Hospital of West Japan Railway Company
Hiroshima, Hiroshima, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
National Hospital Organization Kure Medical Center
Kure, Hiroshima, Japan
Shobara Red Cross Hospital
Shōbara, Hiroshima, Japan
Hokkaido P.W.F.A.C Asahikawa-Kosei General Hospital
Asahikawa, Hokkaido, Japan
Kihara cardiovascular clinic
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
KKR Sapporo Medical Center
Sapporo, Hokkaido, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, Japan
Sapporo Medical Center NTT East
Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Sunagawa City Medical Center
Sunagawa, Hokkaido, Japan
Hyogo Brain and Heart Center
Himeji, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Hyogo College Of Medicine
Nishinomiya, Hyōgo, Japan
Nishiwaki Municipal Hospital
Nishiwaki, Hyōgo, Japan
Hitachi General Hospital
Hitachi, Ibaraki, Japan
Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kagawa University
Kita-gun, Kagawa-ken, Japan
Tenyoukai Central Hospital
Kagoshima, Kagoshima-ken, Japan
St. Marianna University School of Medicine
Kawasaki, Kanagawa, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Nishi Yokohama Hospital
Yokohama, Kanagawa, Japan
Yokohamashintoshi Neurosurgical Hospital
Yokohama, Kanagawa, Japan
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Takenaka Clinic
Kyoto, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Nagasaki Goto Chuoh Hospital
Gotō, Nagasaki, Japan
Ebisu-hospital
Nagasaki, Nagasaki, Japan
Medical Inc. Kosei-kai Nijigaoka Hospital
Nagasaki, Nagasaki, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
Nara Hospital Kinki University Faculty of Medicine
Ikoma, Nara, Japan
Nara Prefecture Western Medical Center
Ikoma, Nara, Japan
Nara Medical University
Kashihara, Nara, Japan
Nara City Hospital
Nara, Nara, Japan
Nara Prefecture General Medical Center
Nara, Nara, Japan
Tsunan Metropolitan Hospital
Nakauonuma-gun, Niigata, Japan
Kuwana hospital
Niigata, Niigata, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Ohama Daiichi Hospital
Naha, Okinawa, Japan
Urasoe General Hospital
Urasoe, Okinawa, Japan
Osaka National Hospital
Chuo, Osaka, Japan
Nozaki Tokushukai Hospital
Daitō, Osaka, Japan
Kansai Medical University Hirakata Hospital
Hirakata, Osaka, Japan
Graduate School of Medicine and Faculty of Medicine
Osaka, Osaka, Japan
JCHO Osaka Hospital
Osaka, Osaka, Japan
Kitano Hospital
Osaka, Osaka, Japan
Sakurabashi Watanabe Hospital
Osaka, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Yayoigaoka Kage Hospital
Tosu, Saga-ken, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Ikebukuro Hospital
Kawagoe, Saitama, Japan
Saitama Medical Center Jichi Medical University
Saitama, Saitama, Japan
Kusatsu General Hospital
Kusatsu, Shiga, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Juntendo Shizuoka Hospital
Izunokuni, Shizuoka, Japan
Dokkyo Medical University
Shimotsuga-gun, Tochigi, Japan
Ohta Clinic
Anan, Tokushima, Japan
Tokushima University Hospital
Tokushima, Tokushima, Japan
Nishiarai Heart Center Hospital
Adachi-ku, Tokyo, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Medical Hospital of Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Tama Medical Center
Fuchū, Tokyo, Japan
Minamino Heart Clinic
Hachiōji, Tokyo, Japan
Hino Municipal Hospital
Hino, Tokyo, Japan
Tokyo Medical Center
Meguro-ku, Tokyo, Japan
100
Setagaya-ku, Tokyo, Japan
Daisankitashinagawa hospital
Shinagawa-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Tottori University Hospital
Yonago, Tottori, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Yamaguchi Grand Medical Center
Hōfu, Yamaguchi, Japan
Shimonoseki City Hospital
Shimonoseki, Yamaguchi, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Kanoiwa General Hospital
Yamanashi, Yamanashi, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hiroyuki Tsutsui
Hokkaido University Graduate School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2014
First Posted
May 14, 2014
Study Start
June 1, 2013
Primary Completion
May 1, 2016
Last Updated
May 14, 2014
Record last verified: 2014-05