Assessment of Beta-Blocker Treatment in Japanese Patients with Chronic Heart Failure

UMIN ID: UMIN000000548

Registered date:13/12/2006

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Chronic heart failure
• Date of first enrollment: 2003/07/01
• Target sample size: 480
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

2.5mg/d: Carvedilol will be up-titrated from 1.25 mg twice daily to the target dose twice daily within an 8 week period based on patient tolerability. Patients will be maintained at the target dose or the maximum tolerated dose for the duration of the study.
5mg/d: Carvedilol will be up-titrated from 1.25 mg twice daily to the target dose twice daily within an 8 week period based on patient tolerability. Patients will be maintained at the target dose or the maximum tolerated dose for the duration of the study.
20mg/d:Carvedilol will be up-titrated from 1.25 mg twice daily to the target dose twice daily within an 8 week period based on patient tolerability. Patients will be maintained at the target dose or the maximum tolerated dose for the duration of the study.

Outcome(s)

• Primary Outcome: a composite of cardiovascular death and unplanned admission to hospital for heart failure
• Secondary Outcome: 1) cardiovascular death, 2) unplanned admission to hospital for heart failure, 3) a need to modify treatment procedures for heart failure, new addition of anti-cardiac failure drugs administered over a 3-day period, 4) death from cardiac failure, 5) sudden death (including death from arrhythmia), 6) aggravation of SAS 1 Met or more, progression of NYHA functional class by 1 grade or more, 7) left ventricular ejection fraction, and 8) BNP.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Primary illness of valvular stenosis, or severe valvular regurgitation. 2) Hypertrophic occlusive cardiomyopathy, restrictive cardiomyopathy, right ventricular cardiomyopathy of arrhythmic origin, or progressive myocarditis 3) Cardiogenic shock patients or patients with systolic blood pressure less than 80mmHg. 4) Severe arrhythmia, bradycardia (>=50 beats/min), or second-degree or higher atrioventricular block. However, cases of temporary bradycardia and Wenckebach second-degree atrioventricular block left to the judgment of the treating physician. 5) Acute myocardial infarction within 3 months prior to the date of consent. 6) Unstable angina pectoris or coronary spasm/rest angina. 7) CABG or PCI within 3 months prior to the date of consent, or patients scheduled for CABG or PCI during the study period. 8) Cerebrovascular accident within 6 months prior to the date of consent. 9) Bronchial asthma or other such chronic respiratory illness, or cor pulmonale. 10) History of malignant tumor or other such life-threatening illness of poor prognosis within 5 years prior to the date of consent. 11) Arteriosclerosis obliterans patients (Fontaine Class 2 or higher). 12) Poorly controlled diabetes. 13) Severe complication by any of the following illnesses: kidney disease , liver disease , anemia. 14) Thyroid dysfunction poorly controlled by treatment. 15) Pregnant, lactating, or possibly pregnant or desiring to become pregnant during the study period. 16) History of drug hypersensitivity to carvedilol. 17) Carvedilol administration is deemed contraindicated. 18) Written consent is not obtained. 19) Other patients deemed unsuitable as subjects of the study by the treating physician.

Related Information

• Primary Sponsor: J-CHF Study Group
• Source(s) of Monetary Support: Japan Heart Foundation