Clinical trial NCT02137733: The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)
Official title: The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Lead sponsor: Mebix Inc
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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:

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 (Coronary artery bypass grafting; CABG, Percutaneous coronary intervention; 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.

Primary outcomes:
measure: Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day)
timeFrame: 48 weeks
Secondary outcomes:
measure: Efficacy: New York Heart Association (NYHA) Functional Classification
timeFrame: 24 and 48 weeks
measure: Efficacy: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 24 and 48 weeks
measure: Efficacy: Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV)
timeFrame: 24 and 48 weeks
measure: Efficacy: Heart rate
timeFrame: 24 and 48 weeks
measure: Efficacy: Plasma brain natriuretic peptide (BNP)
timeFrame: 24 and 48 weeks
measure: Safety: All deaths
timeFrame: 48 weeks
measure: Safety: Deaths with cardiovascular causes
timeFrame: 48 weeks
measure: Safety: Hospitalization for cardiovascular causes
timeFrame: 48 weeks
measure: 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.
timeFrame: 48 weeks
measure: Safety: Deaths due to heart failure (pump-failure deaths, and deaths associated with exacerbation of heart failure)
timeFrame: 48 weeks
measure: Safety: Sudden deaths, including deaths due to arrhythmia
timeFrame: 48 weeks
measure: Safety: Deaths with non-cardiovascular causes
timeFrame: 48 weeks
measure: Safety: Adverse events
timeFrame: 48 weeks
measure: Safety: Changes in clinical laboratory test results
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Banbuntane Hotokukai Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Chukyo Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Takezawa Clinic
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University School of Medicine & Hospital
state: Aomori
city: Matsuyama
country: Japan
facility: Ehime Prefectural Central Hospital
state: Ehime
city: Matsuyama
country: Japan
facility: Saiseikai Matsuyama Hospital
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Kitakyushu
country: Japan
facility: Chiyo Clinic
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kitakyushu Municipal Yahata Hospital
state: Fukuoka
city: Okawa
country: Japan
facility: Takagi Hospital
state: Fukuoka
city: Minokamo
country: Japan
facility: Kizawa memorial hospital
state: Gifu
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Maebashi
country: Japan
facility: Gunmaken Saiseikai Maebashi Hospital
state: Gunma
city: Maebashi
country: Japan
facility: Maebashi Red Cross Hospital
state: Gunma
city: Fukuyama
country: Japan
facility: Ota Memorial Hospital
state: Hiroshima
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center
state: Hiroshima
city: Shobara
country: Japan
facility: Shobara Red Cross Hospital
state: Hiroshima
city: Asahikawa
country: Japan
facility: Hokkaido P.W.F.A.C Asahikawa-Kosei General Hospital
state: Hokkaido
city: Asahikawa
country: Japan
facility: Kihara cardiovascular clinic
state: Hokkaido
city: Ebetsu
country: Japan
facility: Ebetsu City Hospital
state: Hokkaido
city: Iwami
country: Japan
facility: Hokkaido Chuo Rosai Hospital
state: Hokkaido
city: Otaru
country: Japan
facility: Otaru Kyokai Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Medical Center
state: Hokkaido
city: Sapporo
country: Japan
facility: JR Sapporo Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: KKR Sapporo Medical Center
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo City General Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical Center NTT East
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Sunagawa
country: Japan
facility: Sunagawa City Medical Center
state: Hokkaido
city: Himeji
country: Japan
facility: Hyogo Brain and Heart Center
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo College Of Medicine
state: Hyogo
city: Nishiwaki
country: Japan
facility: Nishiwaki Municipal Hospital
state: Hyogo
city: Hitachi
country: Japan
facility: Hitachi General Hospital
state: Ibaraki
city: Kanazawa
country: Japan
facility: Kanazawa Cardiovascular Hospital
state: Ishikawa
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kita-gun
country: Japan
facility: Kagawa University
state: Kagawa
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Nishi Yokohama Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohamashintoshi Neurosurgical Hospital
state: Kanagawa
city: Nankoku
country: Japan
facility: Kochi Medical School Hospital
state: Kochi
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Goto
country: Japan
facility: Nagasaki Goto Chuoh Hospital
state: Nagasaki
city: Ikoma
country: Japan
facility: Nara Hospital Kinki University Faculty of Medicine
state: Nara
city: Ikoma
country: Japan
facility: Nara Prefecture Western Medical Center
state: Nara
city: Kashihara
country: Japan
facility: Nara Medical University
state: Nara
city: Nakauonuma-gun
country: Japan
facility: Tsunan Metropolitan Hospital
state: Niigata
city: Naha
country: Japan
facility: Ohama Daiichi Hospital
state: Okinawa
city: Urasoe
country: Japan
facility: Urasoe General Hospital
state: Okinawa
city: Chuo
country: Japan
facility: Osaka National Hospital
state: Osaka
city: Daito
country: Japan
facility: Nozaki Tokushukai Hospital
state: Osaka
city: Hirakata
country: Japan
facility: Kansai Medical University Hirakata Hospital
state: Osaka
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Tosu
country: Japan
facility: Yayoigaoka Kage Hospital
state: Saga
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Kawagoe
country: Japan
facility: Ikebukuro Hospital
state: Saitama
city: Kusatsu
country: Japan
facility: Kusatsu General Hospital
state: Shiga
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Izunokuni
country: Japan
facility: Juntendo Shizuoka Hospital
state: Shizuoka
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University
state: Tochigi
city: Anan
country: Japan
facility: Ohta Clinic
state: Tokushima
city: Adachi-ku
country: Japan
facility: Nishiarai Heart Center Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Medical Hospital of Tokyo Medical and Dental University
state: Tokyo
city: Fuchu
country: Japan
facility: Tokyo Metropolitan Tama Medical Center
state: Tokyo
city: Hachioji
country: Japan
facility: Minamino Heart Clinic
state: Tokyo
city: Hino
country: Japan
facility: Hino Municipal Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: Tokyo Medical Center
state: Tokyo
city: Setagaya-ku
country: Japan
facility: 100
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Daisankitashinagawa hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Hofu
country: Japan
facility: Yamaguchi Grand Medical Center
state: Yamaguchi
city: Shimonoseki
country: Japan
facility: Shimonoseki City Hospital
state: Yamaguchi
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukuoka
country: Japan
facility: Hakujyuji Hospital
city: Fukuoka
country: Japan
facility: Haradoi Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Fukushima
country: Japan
facility: Fukushima Daiichi Hospital
city: Fukushima
country: Japan
facility: Ohara General Hospital
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima General Hospital of West Japan Railway Company
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kagoshima
country: Japan
facility: Tenyoukai Central Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Kyoto
country: Japan
facility: Takenaka Clinic
city: Nagasaki
country: Japan
facility: Ebisu-hospital
city: Nagasaki
country: Japan
facility: Medical Inc. Kosei-kai Nijigaoka Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nara
country: Japan
facility: Nara City Hospital
city: Nara
country: Japan
facility: Nara Prefecture General Medical Center
city: Niigata
country: Japan
facility: Kuwana hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Graduate School of Medicine and Faculty of Medicine
city: Osaka
country: Japan
facility: JCHO Osaka Hospital
city: Osaka
country: Japan
facility: Kitano Hospital
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Saitama
country: Japan
facility: Saitama Medical Center Jichi Medical University
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yamanashi
country: Japan
facility: Kanoiwa General Hospital
Study officials:
affiliation: Hokkaido University Graduate School of Medicine
name: Hiroyuki Tsutsui
role: STUDY_CHAIR
References: