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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02137733
Recruitment Status : Unknown
Verified May 2014 by Mebix Inc.
Recruitment status was:  Recruiting
First Posted : May 14, 2014
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Mebix Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: Bisoprolol Drug: Carvedilol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Cardiac Insufficiency BIsoprolol Study in Japanese Patients With Chronic Heart Failure (CIBIS-J)
Study Start Date : June 2013
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bisoprolol group
Daily 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).
 Drug: Bisoprolol
Active Comparator: Carvedilol group
Daily 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).
 Drug: Carvedilol


Outcome Measures
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Primary Outcome Measures :
  1. Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day) [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Efficacy: New York Heart Association (NYHA) Functional Classification [ Time Frame: 24 and 48 weeks ]
  2. Efficacy: Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 24 and 48 weeks ]
  3. Efficacy: Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV) [ Time Frame: 24 and 48 weeks ]
  4. Efficacy: Heart rate [ Time Frame: 24 and 48 weeks ]
  5. Efficacy: Plasma brain natriuretic peptide (BNP) [ Time Frame: 24 and 48 weeks ]
  6. Safety: All deaths [ Time Frame: 48 weeks ]
  7. Safety: Deaths with cardiovascular causes [ Time Frame: 48 weeks ]
  8. Safety: Hospitalization for cardiovascular causes [ Time Frame: 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. [ Time Frame: 48 weeks ]
  10. Safety: Deaths due to heart failure (pump-failure deaths, and deaths associated with exacerbation of heart failure) [ Time Frame: 48 weeks ]
  11. Safety: Sudden deaths, including deaths due to arrhythmia [ Time Frame: 48 weeks ]
  12. Safety: Deaths with non-cardiovascular causes [ Time Frame: 48 weeks ]
  13. Safety: Adverse events [ Time Frame: 48 weeks ]
  14. Safety: Changes in clinical laboratory test results [ Time Frame: 48 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137733


Contacts
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Contact: Yukio Yamada 03-6229-8936 Cibis-j@mebix.co.jp

Locations
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Sponsors and Collaborators
Mebix Inc
Investigators
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Study Chair: Hiroyuki Tsutsui Hokkaido University Graduate School of Medicine
More Information
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Responsible Party: Mebix Inc
ClinicalTrials.gov Identifier: NCT02137733    
Other Study ID Numbers: Ji 012-0386
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Carvedilol
Bisoprolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
 Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists