Chronic Heart Failure
Conditions
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.
Interventions
DRUGBisoprolol
DRUGCarvedilol
Sponsors
Mebix Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability: The probability that administered maintenance dose reaches the maximum (bisoprolol 5 mg/day, carvedilol 20 mg/day) | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Left Ventricular Ejection Fraction (LVEF) | 24 and 48 weeks |
| Efficacy: Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV) | 24 and 48 weeks |
| Efficacy: Heart rate | 24 and 48 weeks |
| Efficacy: Plasma brain natriuretic peptide (BNP) | 24 and 48 weeks |
| Safety: All deaths | 48 weeks |
| Safety: Deaths with cardiovascular causes | 48 weeks |
| Efficacy: New York Heart Association (NYHA) Functional Classification | 24 and 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. | 48 weeks |
| Safety: Deaths due to heart failure (pump-failure deaths, and deaths associated with exacerbation of heart failure) | 48 weeks |
| Safety: Sudden deaths, including deaths due to arrhythmia | 48 weeks |
| Safety: Deaths with non-cardiovascular causes | 48 weeks |
| Safety: Adverse events | 48 weeks |
| Safety: Changes in clinical laboratory test results | 48 weeks |
| Safety: Hospitalization for cardiovascular causes | 48 weeks |
Countries
Japan
Contacts
Primary ContactYukio Yamada
Outcome results
None listed