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Chronic Heart FailureNCT02137733

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

A study testing Bisoprolol and Carvedilol in people with Chronic Heart Failure, run by Mebix Inc at 110 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
Bisoprolol and Carvedilol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
110 sitesJapan
Study dates
Jun 2013to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

110 sites in 1 country.

Yukio Yamada contact

03-6229-8936

Cibis-j@mebix.co.jp

110 sites in 1 country

Japan110 sites, 110 recruiting

  • Nishiarai Heart Center Hospital

    Adachi-ku, Tokyo

    Katsumi Saito, 03-5838-0730

    Recruiting

  • Akita University Hospital

    Akita, Akita

    Hiroshi Ito, 018-834-1111

    Recruiting

  • Ohta Clinic

    Anan, Tokushima

    Akira Ohta, 0883-36-2076

    Recruiting

  • Hokkaido P.W.F.A.C Asahikawa-Kosei General Hospital

    Asahikawa, Hokkaido

    Yuji Ogawa, 0166-33-7171

    Recruiting

  • Kihara cardiovascular clinic

    Asahikawa, Hokkaido

    Hajime Kihara, 0166-35-5555

    Recruiting

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo

    Atsutoshi Takagi, 03-3813-3111

    Recruiting

  • Medical Hospital of Tokyo Medical and Dental University

    Bunkyo-ku, Tokyo

    Yasuhiro Maejima, 03-3813-6111

    Recruiting

  • Osaka National Hospital

    Chuo, Osaka

    Keiji Hirooka, 06-6942-1331

    Recruiting

  • Nozaki Tokushukai Hospital

    Daitō, Osaka

    Masaaki Okutsu, 072-874-1641

    Recruiting

  • Ebetsu City Hospital

    Ebetsu, Hokkaido

    Kenji Aoki, 011-382-5151

    Recruiting

  • Tokyo Metropolitan Tama Medical Center

    Fuchū, Tokyo

    Hiroyuki Tanaka, 042-323-5111

    Recruiting

  • Hakujyuji Hospital

    Fukuoka, Fukuoka

    Nobuhide Tanaka, 092-891-2511

    Recruiting

  • Haradoi Hospital

    Fukuoka, Fukuoka

    Takaaki Sakai, 092-691-3881

    Recruiting

  • Kyushu University Hospital

    Fukuoka, Fukuoka

    Tomomi Ide, 092-641-1151

    Recruiting

  • Saiseikai Fukuoka General Hospital

    Fukuoka, Fukuoka

    Ryuichi Matsukawa, 092-771-8151

    Recruiting

  • Fukushima Daiichi Hospital

    Fukushima, Fukushima

    Tomohiro Ogawa, 024-557-5111

    Recruiting

  • Ohara General Hospital

    Fukushima, Fukushima

    Osamu Yamaguchi, 024-554-2001

    Recruiting

  • Ota Memorial Hospital

    Fukuyama, Hiroshima

    Kotaro Yasuda, 084-931-8650

    Recruiting

  • Gifu University Hospital

    Gifu, Gifu

    Shinya Minatokuchi, 058-230-6000

    Recruiting

  • Nagasaki Goto Chuoh Hospital

    Gotō, Nagasaki

    Saburo Kusumoto, 0959-72-3181

    Recruiting

  • Minamino Heart Clinic

    Hachiōji, Tokyo

    Yoshiki Hata, 042-637-8101

    Recruiting

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka

    Hideharu Hayashi, 053-435-2111

    Recruiting

  • Saitama Medical University International Medical Center

    Hidaka, Saitama

    Toshihiko Muramatsu, 042-984-4111

    Recruiting

  • Hyogo Brain and Heart Center

    Himeji, Hyōgo

    Yoshinori Yasaka, 079-293-3131

    Recruiting

  • Hino Municipal Hospital

    Hino, Tokyo

    Iwao Nakamura, 042-581-2677

    Recruiting

  • Kansai Medical University Hirakata Hospital

    Hirakata, Osaka

    Ichiro Shiojima, 072-804-0101

    Recruiting

  • Hirosaki University School of Medicine & Hospital

    Hirosaki, Aomori

    Shingo Sasaki, 0172-33-5111

    Recruiting

  • Hiroshima General Hospital of West Japan Railway Company

    Hiroshima, Hiroshima

    Hiroki Teragawa, 082-262-1171

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, Hiroshima

    Yasuki Kihara, 082-257-5555

    Recruiting

  • Hitachi General Hospital

    Hitachi, Ibaraki

    Yutaka Eki, 0294-23-1111

    Recruiting

  • Yamaguchi Grand Medical Center

    Hōfu, Yamaguchi

    Masashi Kanemoto, 0835-22-4411

    Recruiting

  • Nara Hospital Kinki University Faculty of Medicine

    Ikoma, Nara

    Manabu Shirotani, 0743-77-0880

    Recruiting

  • Nara Prefecture Western Medical Center

    Ikoma, Nara

    Naofumi Doi, 0745-32-0505

    Recruiting

  • Hokkaido Chuo Rosai Hospital

    Iwami, Hokkaido

    Hideyuki Takano, 0126-22-1300

    Recruiting

  • Juntendo Shizuoka Hospital

    Izunokuni, Shizuoka

    Satoru Suwa, 055-948-3111

    Recruiting

  • Tenyoukai Central Hospital

    Kagoshima, Kagoshima-ken

    Nobuhiko Atsuchi, 099-225-8650

    Recruiting

  • Kanazawa Cardiovascular Hospital

    Kanazawa, Ishikawa-ken

    Masatoshi Ikeda, 076-253-8000

    Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken

    Masakazu Yamagishi, 076-265-2000

    Recruiting

  • Nara Medical University

    Kashihara, Nara

    Yoshihiko Saito, 0744-22-3051

    Recruiting

  • Ikebukuro Hospital

    Kawagoe, Saitama

    Hideo Nakahara, 049-231-1552

    Recruiting

  • St. Marianna University School of Medicine

    Kawasaki, Kanagawa

    Keisuke Kida, 044-977-8111

    Recruiting

  • Kagawa University

    Kita-gun, Kagawa-ken

    Koji Ohmori, 087-898-5111

    Recruiting

  • Chiyo Clinic

    Kitakyushu, Fukuoka

    Hiroyoshi Hirayama, 093-614-5558

    Recruiting

  • Kitakyushu Municipal Yahata Hospital

    Kitakyushu, Fukuoka

    Kiyoshi Ozumi, 093-662-6565

    Recruiting

  • Kobe University Hospital

    Kobe, Hyōgo

    Kenichi Hirata, 078-382-5111

    Recruiting

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi

    Masahiko Nakamura, 055-253-7111

    Recruiting

  • Kumamoto University Hospital

    Kumamoto, Kumamoto

    Megumi Yamamuro, 096-344-2111

    Recruiting

  • National Hospital Organization Kure Medical Center

    Kure, Hiroshima

    Ritsu Tamura, 0823-22-3111

    Recruiting

  • Kusatsu General Hospital

    Kusatsu, Shiga

    Atsuyuki Wada, 077-563-8866

    Recruiting

  • Kyoto University Hospital

    Kyoto, Kyoto

    Tsuyoshi Kimura, 075-751-3111

    Recruiting

  • Takenaka Clinic

    Kyoto, Kyoto

    Ken Takenaka, 075-841-4777

    Recruiting

  • Gunma University Hospital

    Maebashi, Gunma

    Norimichi Koitabashi, 027-220-7111

    Recruiting

  • Gunmaken Saiseikai Maebashi Hospital

    Maebashi, Gunma

    Akihiko Nakano, 027-252-6011

    Recruiting

  • Maebashi Red Cross Hospital

    Maebashi, Gunma

    Shoichi Tange, 027-224-4585

    Recruiting

  • Ehime Prefectural Central Hospital

    Matsuyama, Ehime

    Hideki Okayama, 089-947-1111

    Recruiting

  • Saiseikai Matsuyama Hospital

    Matsuyama, Ehime

    Koki Watanabe, 089-951-6111

    Recruiting

  • Tokyo Medical Center

    Meguro-ku, Tokyo

    Yukihiko Momiyama, 03-3411-0111

    Recruiting

  • Kizawa memorial hospital

    Minokamo, Gifu

    Takuma Aoyama, 0574-25-2181

    Recruiting

  • Ebisu-hospital

    Nagasaki, Nagasaki

    Shin Suzuki, 095-824-9131

    Recruiting

  • Medical Inc. Kosei-kai Nijigaoka Hospital

    Nagasaki, Nagasaki

    Minoru Hazama, 095-856-1112

    Recruiting

  • Nagasaki University Hospital

    Nagasaki, Nagasaki

    Koji Maemura, 095-819-7200

    Recruiting

  • Banbuntane Hotokukai Hospital

    Nagoya, Aichi-ken

    Hideo Izawa, 052-321-8171

    Recruiting

  • Chukyo Hospital

    Nagoya, Aichi-ken

    Naoya Tsuboi, 052-691-7151

    Recruiting

  • Nagoya City University Hospital

    Nagoya, Aichi-ken

    Hidekatsu Fukuda, 052-851-5511

    Recruiting

  • Takezawa Clinic

    Nagoya, Aichi-ken

    Hiroto Takezawa, 052-837-7500

    Recruiting

  • Ohama Daiichi Hospital

    Naha, Okinawa

    Koichi Ohshiro, 098-866-5171

    Recruiting

  • Tsunan Metropolitan Hospital

    Nakauonuma-gun, Niigata

    Shinichiro Ishikawa, 025-765-3161

    Recruiting

  • Kochi Medical School Hospital

    Nankoku, Kochi

    Hiroaki Kitaoka, 088-866-5811

    Recruiting

  • Nara City Hospital

    Nara, Nara

    Manabu Horii, 0742-24-1251

    Recruiting

  • Nara Prefecture General Medical Center

    Nara, Nara

    Fumitaka Inoue, 0742-46-6001

    Recruiting

  • Kuwana hospital

    Niigata, Niigata

    Shiro Minagawa, 025-273-2251

    Recruiting

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata

    Tohru Minamino, 025-223-6161

    Recruiting

  • Hyogo College Of Medicine

    Nishinomiya, Hyōgo

    Tohru Masuyama, 0798-45-6111

    Recruiting

  • Nishiwaki Municipal Hospital

    Nishiwaki, Hyōgo

    Ryuichiro Shimao, 0795-22-0111

    Recruiting

  • Takagi Hospital

    Ōkawa, Fukuoka

    Tsuyoshi Yoshihiro, 0944-87-0001

    Recruiting

  • Okayama University Hospital

    Okayama, Okayama-ken

    Kazufumi Nakamura, 086-223-7151

    Recruiting

  • Graduate School of Medicine and Faculty of Medicine

    Osaka, Osaka

    Akihisa Hanatani, 06-6645-2121

    Recruiting

  • JCHO Osaka Hospital

    Osaka, Osaka

    Shinji Hasegawa, 06-6411-5451

    Recruiting

  • Kitano Hospital

    Osaka, Osaka

    Takao Kato, 06-6312-1221

    Recruiting

  • Sakurabashi Watanabe Hospital

    Osaka, Osaka

    Kenji Fujii, 06-6341-8651

    Recruiting

  • Otaru Kyokai Hospital

    Otaru, Hokkaido

    Shigeo Kakinoki, 0134-23-6234

    Recruiting

  • Kitasato University Hospital

    Sagamihara, Kanagawa

    Takashi Naruke, 042-778-8111

    Recruiting

  • Saitama Medical Center Jichi Medical University

    Saitama, Saitama

    Shinichi Momomura, 048-647-2111

    Recruiting

  • Hokkaido Medical Center

    Sapporo, Hokkaido

    Hiroshi Okamoto, 011-611-8111

    Recruiting

  • JR Sapporo Hospital

    Sapporo, Hokkaido

    Akihito Tsuchida, 011-208-7150

    Recruiting

  • KKR Sapporo Medical Center

    Sapporo, Hokkaido

    Naofumi Ito, 011-841-4572

    Recruiting

  • Sapporo City General Hospital

    Sapporo, Hokkaido

    Tetsuro Kohya, 011-726-2211

    Recruiting

  • Sapporo Medical Center NTT East

    Sapporo, Hokkaido

    Noriyuki Miyamoto, 011-623-7000

    Recruiting

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido

    Tetsuji Miura, 011-611-2111

    Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi

    Hiroaki Shimokawa, 022-717-7000

    Recruiting

  • 100

    Setagaya-ku, Tokyo

    Takashi Matsuo, 03-6411-3666

    Recruiting

  • Shimonoseki City Hospital

    Shimonoseki, Yamaguchi

    Eiji Karashima, 083-231-4111

    Recruiting

  • Dokkyo Medical University

    Shimotsuga-gun, Tochigi

    Shigeru Toyoda, 0282-86-1111

    Recruiting

  • Daisankitashinagawa hospital

    Shinagawa-ku, Tokyo

    Tsuneo Mizumura, 03-3474-1831

    Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo

    Akira Yamashina, 03-3342-6111

    Recruiting

  • Shobara Red Cross Hospital

    Shōbara, Hiroshima

    Hiroshi Sugino, 0824-72-3111

    Recruiting

  • National Cerebral and Cardiovascular Center

    Suita, Osaka

    Toshihisa Anzai, 06-6833-5012

    Recruiting

  • Osaka University Hospital

    Suita, Osaka

    Tomohito Ohtani, 06-6879-5111

    Recruiting

  • Sunagawa City Medical Center

    Sunagawa, Hokkaido

    Takayuki Hirabayashi, 0125-54-2131

    Recruiting

  • Tokushima University Hospital

    Tokushima, Tokushima

    Masataka Sata, 088-631-3111

    Recruiting

  • Ehime University Hospital

    Tōon, Ehime

    Akiyoshi Ogimoto, 089-964-5111

    Recruiting

  • Yayoigaoka Kage Hospital

    Tosu, Saga-ken

    Masaru Takahashi, 0942-87-3150

    Recruiting

  • Yamaguchi University Hospital

    Ube, Yamaguchi

    Shigeki Kobayashi, 0836-22-2111

    Recruiting

  • Urasoe General Hospital

    Urasoe, Okinawa

    Hiroki Uehara, 098-878-0231

    Recruiting

  • Wakayama Medical University Hospital

    Wakayama, Wakayama

    Takashi Akasaka, 073-447-2300

    Recruiting

  • Kanoiwa General Hospital

    Yamanashi, Yamanashi

    Kimio Yamamoto, 0553-22-2511

    Recruiting

  • Nishi Yokohama Hospital

    Yokohama, Kanagawa

    Hideshi Takenobu, 045-871-8855

    Recruiting

  • Yokohamashintoshi Neurosurgical Hospital

    Yokohama, Kanagawa

    Kazuhiro Ashida, 045-911-2011

    Recruiting

  • Tottori University Hospital

    Yonago, Tottori

    Ryoji Kinugasa, 0859-33-1111

    Recruiting

  • University of Fukui Hospital

    Yoshida-gun, Fukui

    Ryuichiro Shimao, 0776-61-3111

    Recruiting

Other trials in Japan

About this study

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.

Being tested
Bisoprolol, Carvedilol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BisoprololDrug

  • CarvedilolDrug

Study groups in NCT02137733
Study groupRoleWhat they receive
Bisoprolol groupActive 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).
Receives: Drug: Bisoprolol
Carvedilol groupActive 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).
Receives: Drug: Carvedilol

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 48 weeks

Secondary outcomes (14)

  1. Efficacy: New York Heart Association (NYHA) Functional Classification

    Measured: 24 and 48 weeks

  2. Efficacy: Left Ventricular Ejection Fraction (LVEF)

    Measured: 24 and 48 weeks

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

    Measured: 24 and 48 weeks

  4. Efficacy: Heart rate

    Measured: 24 and 48 weeks

  5. Efficacy: Plasma brain natriuretic peptide (BNP)

    Measured: 24 and 48 weeks

  6. Safety: All deaths

    Measured: 48 weeks

  7. Safety: Deaths with cardiovascular causes

    Measured: 48 weeks

  8. Safety: Hospitalization for cardiovascular causes

    Measured: 48 weeks

  9. 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.

    Measured: 48 weeks

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

    Measured: 48 weeks

  11. Safety: Sudden deaths, including deaths due to arrhythmia

    Measured: 48 weeks

  12. Safety: Deaths with non-cardiovascular causes

    Measured: 48 weeks

  13. Safety: Adverse events

    Measured: 48 weeks

  14. Safety: Changes in clinical laboratory test results

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2014 (estimated)
  2. Study startJun 2013
  3. Primary completionMay 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02137733
Sponsor's protocol ID
Ji 012-0386
Status last verified
May 2014
First submitted
1 May 2014
Last updated
14 May 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Bisoprolol and Carvedilol in people with Chronic Heart Failure, run by Mebix Inc at 110 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yukio Yamada (03-6229-8936, Cibis-j@mebix.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02137733.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.

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