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

Information source: Mebix Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Heart Failure

Intervention: Bisoprolol (Drug); Carvedilol (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Mebix Inc

Official(s) and/or principal investigator(s):
Hiroyuki Tsutsui, Study Chair, Affiliation: Hokkaido University Graduate School of Medicine

Overall contact:
Yukio Yamada, Phone: 03-6229-8936, Email: Cibis-j@mebix.co.jp

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.

Clinical Details

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

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

Primary outcome: Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day)

Secondary outcome:

Efficacy: New York Heart Association (NYHA) Functional Classification

Efficacy: Left Ventricular Ejection Fraction (LVEF)

Efficacy: Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV)

Efficacy: Heart rate

Efficacy: Plasma brain natriuretic peptide (BNP)

Safety: All deaths

Safety: Deaths with cardiovascular causes

Safety: Hospitalization for cardiovascular causes

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.

Safety: Deaths due to heart failure (pump-failure deaths, and deaths associated with exacerbation of heart failure)

Safety: Sudden deaths, including deaths due to arrhythmia

Safety: Deaths with non-cardiovascular causes

Safety: Adverse events

Safety: Changes in clinical laboratory test results

Eligibility

Minimum age: 20 Years. Maximum age: 85 Years. Gender(s): Both.

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.

Locations and Contacts

Yukio Yamada, Phone: 03-6229-8936, Email: Cibis-j@mebix.co.jp

Akita University Hospital, Akita, Japan; Recruiting
Hiroshi Ito, Phone: 018-834-1111

Hakujyuji Hospital, Fukuoka, Japan; Recruiting
Nobuhide Tanaka, Phone: 092-891-2511

Haradoi Hospital, Fukuoka, Japan; Recruiting
Takaaki Sakai, Phone: 092-691-3881

Kyushu University Hospital, Fukuoka, Japan; Recruiting
Tomomi Ide, Phone: 092-641-1151

Saiseikai Fukuoka General Hospital, Fukuoka, Japan; Recruiting
Ryuichi Matsukawa, Phone: 092-771-8151

Fukushima Daiichi Hospital, Fukushima, Japan; Recruiting
Tomohiro Ogawa, Phone: 024-557-5111

Ohara General Hospital, Fukushima, Japan; Recruiting
Osamu Yamaguchi, Phone: 024-554-2001

Gifu University Hospital, Gifu, Japan; Recruiting
Shinya Minatokuchi, Phone: 058-230-6000

Hiroshima General Hospital of West Japan Railway Company, Hiroshima, Japan; Recruiting
Hiroki Teragawa, Phone: 082-262-1171

Hiroshima University Hospital, Hiroshima, Japan; Recruiting
Yasuki Kihara, Phone: 082-257-5555

Tenyoukai Central Hospital, Kagoshima, Japan; Recruiting
Nobuhiko Atsuchi, Phone: 099-225-8650

Kumamoto University Hospital, Kumamoto, Japan; Recruiting
Megumi Yamamuro, Phone: 096-344-2111

Kyoto University Hospital, Kyoto, Japan; Recruiting
Tsuyoshi Kimura, Phone: 075-751-3111

Takenaka Clinic, Kyoto, Japan; Recruiting
Ken Takenaka, Phone: 075-841-4777

Ebisu-hospital, Nagasaki, Japan; Recruiting
Shin Suzuki, Phone: 095-824-9131

Medical Inc. Kosei-kai Nijigaoka Hospital, Nagasaki, Japan; Recruiting
Minoru Hazama, Phone: 095-856-1112

Nagasaki University Hospital, Nagasaki, Japan; Recruiting
Koji Maemura, Phone: 095-819-7200

Nara City Hospital, Nara, Japan; Recruiting
Manabu Horii, Phone: 0742-24-1251

Nara Prefecture General Medical Center, Nara, Japan; Recruiting
Fumitaka Inoue, Phone: 0742-46-6001

Kuwana hospital, Niigata, Japan; Recruiting
Shiro Minagawa, Phone: 025-273-2251

Niigata University Medical & Dental Hospital, Niigata, Japan; Recruiting
Tohru Minamino, Phone: 025-223-6161

Okayama University Hospital, Okayama, Japan; Recruiting
Kazufumi Nakamura, Phone: 086-223-7151

Graduate School of Medicine and Faculty of Medicine, Osaka, Japan; Recruiting
Akihisa Hanatani, Phone: 06-6645-2121

JCHO Osaka Hospital, Osaka, Japan; Recruiting
Shinji Hasegawa, Phone: 06-6411-5451

Kitano Hospital, Osaka, Japan; Recruiting
Takao Kato, Phone: 06-6312-1221

Sakurabashi Watanabe Hospital, Osaka, Japan; Recruiting
Kenji Fujii, Phone: 06-6341-8651

Saitama Medical Center Jichi Medical University, Saitama, Japan; Recruiting
Shinichi Momomura, Phone: 048-647-2111

Tokushima University Hospital, Tokushima, Japan; Recruiting
Masataka Sata, Phone: 088-631-3111

Wakayama Medical University Hospital, Wakayama, Japan; Recruiting
Takashi Akasaka, Phone: 073-447-2300

Kanoiwa General Hospital, Yamanashi, Japan; Recruiting
Kimio Yamamoto, Phone: 0553-22-2511

Banbuntane Hotokukai Hospital, Nagoya, Aichi, Japan; Recruiting
Hideo Izawa, Phone: 052-321-8171

Chukyo Hospital, Nagoya, Aichi, Japan; Recruiting
Naoya Tsuboi, Phone: 052-691-7151

Nagoya City University Hospital, Nagoya, Aichi, Japan; Recruiting
Hidekatsu Fukuda, Phone: 052-851-5511

Takezawa Clinic, Nagoya, Aichi, Japan; Recruiting
Hiroto Takezawa, Phone: 052-837-7500

Hirosaki University School of Medicine & Hospital, Hirosaki, Aomori, Japan; Recruiting
Shingo Sasaki, Phone: 0172-33-5111

Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan; Recruiting
Hideki Okayama, Phone: 089-947-1111

Saiseikai Matsuyama Hospital, Matsuyama, Ehime, Japan; Recruiting
Koki Watanabe, Phone: 089-951-6111

Ehime University Hospital, Toon, Ehime, Japan; Recruiting
Akiyoshi Ogimoto, Phone: 089-964-5111

University of Fukui Hospital, Yoshida-gun, Fukui, Japan; Recruiting
Ryuichiro Shimao, Phone: 0776-61-3111

Chiyo Clinic, Kitakyushu, Fukuoka, Japan; Recruiting
Hiroyoshi Hirayama, Phone: 093-614-5558

Kitakyushu Municipal Yahata Hospital, Kitakyushu, Fukuoka, Japan; Recruiting
Kiyoshi Ozumi, Phone: 093-662-6565

Takagi Hospital, Okawa, Fukuoka, Japan; Recruiting
Tsuyoshi Yoshihiro, Phone: 0944-87-0001

Kizawa memorial hospital, Minokamo, Gifu, Japan; Recruiting
Takuma Aoyama, Phone: 0574-25-2181

Gunma University Hospital, Maebashi, Gunma, Japan; Recruiting
Norimichi Koitabashi, Phone: 027-220-7111

Gunmaken Saiseikai Maebashi Hospital, Maebashi, Gunma, Japan; Recruiting
Akihiko Nakano, Phone: 027-252-6011

Maebashi Red Cross Hospital, Maebashi, Gunma, Japan; Recruiting
Shoichi Tange, Phone: 027-224-4585

Ota Memorial Hospital, Fukuyama, Hiroshima, Japan; Recruiting
Kotaro Yasuda, Phone: 084-931-8650

National Hospital Organization Kure Medical Center, Kure, Hiroshima, Japan; Recruiting
Ritsu Tamura, Phone: 0823-22-3111

Shobara Red Cross Hospital, Shobara, Hiroshima, Japan; Recruiting
Hiroshi Sugino, Phone: 0824-72-3111

Hokkaido P.W.F.A.C Asahikawa-Kosei General Hospital, Asahikawa, Hokkaido, Japan; Recruiting
Yuji Ogawa, Phone: 0166-33-7171

Kihara cardiovascular clinic, Asahikawa, Hokkaido, Japan; Recruiting
Hajime Kihara, Phone: 0166-35-5555

Ebetsu City Hospital, Ebetsu, Hokkaido, Japan; Recruiting
Kenji Aoki, Phone: 011-382-5151

Hokkaido Chuo Rosai Hospital, Iwami, Hokkaido, Japan; Recruiting
Hideyuki Takano, Phone: 0126-22-1300

Otaru Kyokai Hospital, Otaru, Hokkaido, Japan; Recruiting
Shigeo Kakinoki, Phone: 0134-23-6234

Hokkaido Medical Center, Sapporo, Hokkaido, Japan; Recruiting
Hiroshi Okamoto, Phone: 011-611-8111

JR Sapporo Hospital, Sapporo, Hokkaido, Japan; Recruiting
Akihito Tsuchida, Phone: 011-208-7150

KKR Sapporo Medical Center, Sapporo, Hokkaido, Japan; Recruiting
Naofumi Ito, Phone: 011-841-4572

Sapporo City General Hospital, Sapporo, Hokkaido, Japan; Recruiting
Tetsuro Kohya, Phone: 011-726-2211

Sapporo Medical Center NTT East, Sapporo, Hokkaido, Japan; Recruiting
Noriyuki Miyamoto, Phone: 011-623-7000

Sapporo Medical University Hospital, Sapporo, Hokkaido, Japan; Recruiting
Tetsuji Miura, Phone: 011-611-2111

Sunagawa City Medical Center, Sunagawa, Hokkaido, Japan; Recruiting
Takayuki Hirabayashi, Phone: 0125-54-2131

Hyogo Brain and Heart Center, Himeji, Hyogo, Japan; Recruiting
Yoshinori Yasaka, Phone: 079-293-3131

Kobe University Hospital, Kobe, Hyogo, Japan; Recruiting
Kenichi Hirata, Phone: 078-382-5111

Hyogo College Of Medicine, Nishinomiya, Hyogo, Japan; Recruiting
Tohru Masuyama, Phone: 0798-45-6111

Nishiwaki Municipal Hospital, Nishiwaki, Hyogo, Japan; Recruiting
Ryuichiro Shimao, Phone: 0795-22-0111

Hitachi General Hospital, Hitachi, Ibaraki, Japan; Recruiting
Yutaka Eki, Phone: 0294-23-1111

Kanazawa Cardiovascular Hospital, Kanazawa, Ishikawa, Japan; Recruiting
Masatoshi Ikeda, Phone: 076-253-8000

Kanazawa University Hospital, Kanazawa, Ishikawa, Japan; Recruiting
Masakazu Yamagishi, Phone: 076-265-2000

Kagawa University, Kita-gun, Kagawa, Japan; Recruiting
Koji Ohmori, Phone: 087-898-5111

St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan; Recruiting
Keisuke Kida, Phone: 044-977-8111

Kitasato University Hospital, Sagamihara, Kanagawa, Japan; Recruiting
Takashi Naruke, Phone: 042-778-8111

Nishi Yokohama Hospital, Yokohama, Kanagawa, Japan; Recruiting
Hideshi Takenobu, Phone: 045-871-8855

Yokohamashintoshi Neurosurgical Hospital, Yokohama, Kanagawa, Japan; Recruiting
Kazuhiro Ashida, Phone: 045-911-2011

Kochi Medical School Hospital, Nankoku, Kochi, Japan; Recruiting
Hiroaki Kitaoka, Phone: 088-866-5811

Tohoku University Hospital, Sendai, Miyagi, Japan; Recruiting
Hiroaki Shimokawa, Phone: 022-717-7000

Nagasaki Goto Chuoh Hospital, Goto, Nagasaki, Japan; Recruiting
Saburo Kusumoto, Phone: 0959-72-3181

Nara Hospital Kinki University Faculty of Medicine, Ikoma, Nara, Japan; Recruiting
Manabu Shirotani, Phone: 0743-77-0880

Nara Prefecture Western Medical Center, Ikoma, Nara, Japan; Recruiting
Naofumi Doi, Phone: 0745-32-0505

Nara Medical University, Kashihara, Nara, Japan; Recruiting
Yoshihiko Saito, Phone: 0744-22-3051

Tsunan Metropolitan Hospital, Nakauonuma-gun, Niigata, Japan; Recruiting
Shinichiro Ishikawa, Phone: 025-765-3161

Ohama Daiichi Hospital, Naha, Okinawa, Japan; Recruiting
Koichi Ohshiro, Phone: 098-866-5171

Urasoe General Hospital, Urasoe, Okinawa, Japan; Recruiting
Hiroki Uehara, Phone: 098-878-0231

Osaka National Hospital, Chuo, Osaka, Japan; Recruiting
Keiji Hirooka, Phone: 06-6942-1331

Nozaki Tokushukai Hospital, Daito, Osaka, Japan; Recruiting
Masaaki Okutsu, Phone: 072-874-1641

Kansai Medical University Hirakata Hospital, Hirakata, Osaka, Japan; Recruiting
Ichiro Shiojima, Phone: 072-804-0101

National Cerebral and Cardiovascular Center, Suita, Osaka, Japan; Recruiting
Toshihisa Anzai, Phone: 06-6833-5012

Osaka University Hospital, Suita, Osaka, Japan; Recruiting
Tomohito Ohtani, Phone: 06-6879-5111

Yayoigaoka Kage Hospital, Tosu, Saga, Japan; Recruiting
Masaru Takahashi, Phone: 0942-87-3150

Saitama Medical University International Medical Center, Hidaka, Saitama, Japan; Recruiting
Toshihiko Muramatsu, Phone: 042-984-4111

Ikebukuro Hospital, Kawagoe, Saitama, Japan; Recruiting
Hideo Nakahara, Phone: 049-231-1552

Kusatsu General Hospital, Kusatsu, Shiga, Japan; Recruiting
Atsuyuki Wada, Phone: 077-563-8866

Hamamatsu University Hospital, Hamamatsu, Shizuoka, Japan; Recruiting
Hideharu Hayashi, Phone: 053-435-2111

Juntendo Shizuoka Hospital, Izunokuni, Shizuoka, Japan; Recruiting
Satoru Suwa, Phone: 055-948-3111

Dokkyo Medical University, Shimotsuga-gun, Tochigi, Japan; Recruiting
Shigeru Toyoda, Phone: 0282-86-1111

Ohta Clinic, Anan, Tokushima, Japan; Recruiting
Akira Ohta, Phone: 0883-36-2076

Nishiarai Heart Center Hospital, Adachi-ku, Tokyo, Japan; Recruiting
Katsumi Saito, Phone: 03-5838-0730

Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan; Recruiting
Atsutoshi Takagi, Phone: 03-3813-3111

Medical Hospital of Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan; Recruiting
Yasuhiro Maejima, Phone: 03-3813-6111

Tokyo Metropolitan Tama Medical Center, Fuchu, Tokyo, Japan; Recruiting
Hiroyuki Tanaka, Phone: 042-323-5111

Minamino Heart Clinic, Hachioji, Tokyo, Japan; Recruiting
Yoshiki Hata, Phone: 042-637-8101

Hino Municipal Hospital, Hino, Tokyo, Japan; Recruiting
Iwao Nakamura, Phone: 042-581-2677

Tokyo Medical Center, Meguro-ku, Tokyo, Japan; Recruiting
Yukihiko Momiyama, Phone: 03-3411-0111

100, Setagaya-ku, Tokyo, Japan; Recruiting
Takashi Matsuo, Phone: 03-6411-3666

Daisankitashinagawa hospital, Shinagawa-ku, Tokyo, Japan; Recruiting
Tsuneo Mizumura, Phone: 03-3474-1831

Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, Japan; Recruiting
Akira Yamashina, Phone: 03-3342-6111

Tottori University Hospital, Yonago, Tottori, Japan; Recruiting
Ryoji Kinugasa, Phone: 0859-33-1111

Yamaguchi Grand Medical Center, Hofu, Yamaguchi, Japan; Recruiting
Masashi Kanemoto, Phone: 0835-22-4411

Shimonoseki City Hospital, Shimonoseki, Yamaguchi, Japan; Recruiting
Eiji Karashima, Phone: 083-231-4111

Yamaguchi University Hospital, Ube, Yamaguchi, Japan; Recruiting
Shigeki Kobayashi, Phone: 0836-22-2111

Yamanashi Prefectural Central Hospital, Kofu, Yamanashi, Japan; Recruiting
Masahiko Nakamura, Phone: 055-253-7111

Additional Information

Starting date: June 2013
Last updated: May 10, 2014

Page last updated: August 23, 2015

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