The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)

Chronic Heart Failure Clinical Trial

Official title:

The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02137733
• Other study ID #: Ji 012-0386
• Status: Recruiting
• Phase: N/A
• First received: May 1, 2014
• Last updated: May 10, 2014
• Start date: June 2013

Study information

• Verified date: May 2014
• Source: Mebix Inc
• Contact: Yukio Yamada
• Phone: 03-6229-8936
• Email: Cibis-j[@]mebix.co.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Bisoprolol

• Carvedilol

Locations

Country	Name	City	State
Japan	Nishiarai Heart Center Hospital	Adachi-ku	Tokyo
Japan	Akita University Hospital	Akita
Japan	Ohta Clinic	Anan	Tokushima
Japan	Hokkaido P.W.F.A.C Asahikawa-Kosei General Hospital	Asahikawa	Hokkaido
Japan	Kihara cardiovascular clinic	Asahikawa	Hokkaido
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Medical Hospital of Tokyo Medical and Dental University	Bunkyo-ku	Tokyo
Japan	Osaka National Hospital	Chuo	Osaka
Japan	Nozaki Tokushukai Hospital	Daito	Osaka
Japan	Ebetsu City Hospital	Ebetsu	Hokkaido
Japan	Tokyo Metropolitan Tama Medical Center	Fuchu	Tokyo
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	Ota Memorial Hospital	Fukuyama	Hiroshima
Japan	Gifu University Hospital	Gifu
Japan	Nagasaki Goto Chuoh Hospital	Goto	Nagasaki
Japan	Minamino Heart Clinic	Hachioji	Tokyo
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Hyogo Brain and Heart Center	Himeji	Hyogo
Japan	Hino Municipal Hospital	Hino	Tokyo
Japan	Kansai Medical University Hirakata Hospital	Hirakata	Osaka
Japan	Hirosaki University School of Medicine & Hospital	Hirosaki	Aomori
Japan	Hiroshima General Hospital of West Japan Railway Company	Hiroshima
Japan	Hiroshima University Hospital	Hiroshima
Japan	Hitachi General Hospital	Hitachi	Ibaraki
Japan	Yamaguchi Grand Medical Center	Hofu	Yamaguchi
Japan	Nara Hospital Kinki University Faculty of Medicine	Ikoma	Nara
Japan	Nara Prefecture Western Medical Center	Ikoma	Nara
Japan	Hokkaido Chuo Rosai Hospital	Iwami	Hokkaido
Japan	Juntendo Shizuoka Hospital	Izunokuni	Shizuoka
Japan	Tenyoukai Central Hospital	Kagoshima
Japan	Kanazawa Cardiovascular Hospital	Kanazawa	Ishikawa
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	Nara Medical University	Kashihara	Nara
Japan	Ikebukuro Hospital	Kawagoe	Saitama
Japan	St. Marianna University School of Medicine	Kawasaki	Kanagawa
Japan	Kagawa University	Kita-gun	Kagawa
Japan	Chiyo Clinic	Kitakyushu	Fukuoka
Japan	Kitakyushu Municipal Yahata Hospital	Kitakyushu	Fukuoka
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Yamanashi Prefectural Central Hospital	Kofu	Yamanashi
Japan	Kumamoto University Hospital	Kumamoto
Japan	National Hospital Organization Kure Medical Center	Kure	Hiroshima
Japan	Kusatsu General Hospital	Kusatsu	Shiga
Japan	Kyoto University Hospital	Kyoto
Japan	Takenaka Clinic	Kyoto
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	Gunmaken Saiseikai Maebashi Hospital	Maebashi	Gunma
Japan	Maebashi Red Cross Hospital	Maebashi	Gunma
Japan	Ehime Prefectural Central Hospital	Matsuyama	Ehime
Japan	Saiseikai Matsuyama Hospital	Matsuyama	Ehime
Japan	Tokyo Medical Center	Meguro-ku	Tokyo
Japan	Kizawa memorial hospital	Minokamo	Gifu
Japan	Ebisu-hospital	Nagasaki
Japan	Medical Inc. Kosei-kai Nijigaoka Hospital	Nagasaki
Japan	Nagasaki University Hospital	Nagasaki
Japan	Banbuntane Hotokukai Hospital	Nagoya	Aichi
Japan	Chukyo Hospital	Nagoya	Aichi
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	Takezawa Clinic	Nagoya	Aichi
Japan	Ohama Daiichi Hospital	Naha	Okinawa
Japan	Tsunan Metropolitan Hospital	Nakauonuma-gun	Niigata
Japan	Kochi Medical School Hospital	Nankoku	Kochi
Japan	Nara City Hospital	Nara
Japan	Nara Prefecture General Medical Center	Nara
Japan	Kuwana hospital	Niigata
Japan	Niigata University Medical & Dental Hospital	Niigata
Japan	Hyogo College Of Medicine	Nishinomiya	Hyogo
Japan	Nishiwaki Municipal Hospital	Nishiwaki	Hyogo
Japan	Takagi Hospital	Okawa	Fukuoka
Japan	Okayama University Hospital	Okayama
Japan	Graduate School of Medicine and Faculty of Medicine	Osaka
Japan	JCHO Osaka Hospital	Osaka
Japan	Kitano Hospital	Osaka
Japan	Sakurabashi Watanabe Hospital	Osaka
Japan	Otaru Kyokai Hospital	Otaru	Hokkaido
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Saitama Medical Center Jichi Medical University	Saitama
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	Tohoku University Hospital	Sendai	Miyagi
Japan	100	Setagaya-ku	Tokyo
Japan	Shimonoseki City Hospital	Shimonoseki	Yamaguchi
Japan	Dokkyo Medical University	Shimotsuga-gun	Tochigi
Japan	Daisankitashinagawa hospital	Shinagawa-ku	Tokyo
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Shobara Red Cross Hospital	Shobara	Hiroshima
Japan	National Cerebral and Cardiovascular Center	Suita	Osaka
Japan	Osaka University Hospital	Suita	Osaka
Japan	Sunagawa City Medical Center	Sunagawa	Hokkaido
Japan	Tokushima University Hospital	Tokushima
Japan	Ehime University Hospital	Toon	Ehime
Japan	Yayoigaoka Kage Hospital	Tosu	Saga
Japan	Yamaguchi University Hospital	Ube	Yamaguchi
Japan	Urasoe General Hospital	Urasoe	Okinawa
Japan	Wakayama Medical University Hospital	Wakayama
Japan	Kanoiwa General Hospital	Yamanashi
Japan	Nishi Yokohama Hospital	Yokohama	Kanagawa
Japan	Yokohamashintoshi Neurosurgical Hospital	Yokohama	Kanagawa
Japan	Tottori University Hospital	Yonago	Tottori
Japan	University of Fukui Hospital	Yoshida-gun	Fukui

Sponsors (1)

Lead Sponsor	Collaborator
Mebix Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day)		48 weeks	No
Secondary	Efficacy: New York Heart Association (NYHA) Functional Classification		24 and 48 weeks	No
Secondary	Efficacy: Left Ventricular Ejection Fraction (LVEF)		24 and 48 weeks	No
Secondary	Efficacy: Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV)		24 and 48 weeks	No
Secondary	Efficacy: Heart rate		24 and 48 weeks	No
Secondary	Efficacy: Plasma brain natriuretic peptide (BNP)		24 and 48 weeks	Yes
Secondary	Safety: All deaths		48 weeks	Yes
Secondary	Safety: Deaths with cardiovascular causes		48 weeks	Yes
Secondary	Safety: Hospitalization for cardiovascular causes		48 weeks	Yes
Secondary	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	Yes
Secondary	Safety: Deaths due to heart failure (pump-failure deaths, and deaths associated with exacerbation of heart failure)		48 weeks	Yes
Secondary	Safety: Sudden deaths, including deaths due to arrhythmia		48 weeks	Yes
Secondary	Safety: Deaths with non-cardiovascular causes		48 weeks	Yes
Secondary	Safety: Adverse events		48 weeks	Yes
Secondary	Safety: Changes in clinical laboratory test results		48 weeks	Yes