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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day)
Time frame: 48 weeks
Efficacy: New York Heart Association (NYHA) Functional Classification
Time frame: 24 and 48 weeks
Efficacy: Left Ventricular Ejection Fraction (LVEF)
Time frame: 24 and 48 weeks
Efficacy: Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV)
Time frame: 24 and 48 weeks
Efficacy: Heart rate
Time frame: 24 and 48 weeks
Efficacy: Plasma brain natriuretic peptide (BNP)
Time frame: 24 and 48 weeks
Safety: All deaths
Time frame: 48 weeks
Safety: Deaths with cardiovascular causes
Time frame: 48 weeks
Safety: Hospitalization for cardiovascular causes
Time frame: 48 weeks
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
Safety: Deaths due to heart failure (pump-failure deaths, and deaths associated with exacerbation of heart failure)
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Banbuntane Hotokukai Hospital
Nagoya, Aichi-ken, Japan
RECRUITINGChukyo Hospital
Nagoya, Aichi-ken, Japan
RECRUITINGNagoya City University Hospital
Nagoya, Aichi-ken, Japan
RECRUITINGTakezawa Clinic
Nagoya, Aichi-ken, Japan
RECRUITINGAkita University Hospital
Akita, Akita, Japan
RECRUITINGHirosaki University School of Medicine & Hospital
Hirosaki, Aomori, Japan
RECRUITINGEhime Prefectural Central Hospital
Matsuyama, Ehime, Japan
RECRUITINGSaiseikai Matsuyama Hospital
Matsuyama, Ehime, Japan
RECRUITINGEhime University Hospital
Tōon, Ehime, Japan
RECRUITINGUniversity of Fukui Hospital
Yoshida-gun, Fukui, Japan
RECRUITING...and 100 more locations
Time frame: 48 weeks
Safety: Sudden deaths, including deaths due to arrhythmia
Time frame: 48 weeks
Safety: Deaths with non-cardiovascular causes
Time frame: 48 weeks
Safety: Adverse events
Time frame: 48 weeks
Safety: Changes in clinical laboratory test results
Time frame: 48 weeks