Chronic heart failure
Conditions
Interventions
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
Sponsors
J-CHF Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Underlying illness: Chronic heart failure patients with stable symptoms (no fluctuation in NYHA heart function class prior to start of drug administration) and not currently taking carvedilol. Definition of "stable": No fluctuation in NYHA heart function class prior to start of drug administration (fluctuation from IIM to III or III to IIM interpreted as stable). 2) Degree of severity: Patients with NYHA heart function class II or III and EF of 40% or lower. 3) Age: Patients age 20 years or older to less than 80 years at the start of the observation period. 4) Inpatient/outpatient status: Without regard to inpatient or outpatient status; however, the time frame and reason for any changes to be noted in study tables. 5) Sex: Without regard to sex.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a composite of cardiovascular death and unplanned admission to hospital for heart failure | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactHiroshi Okamoto
Nishi Sapporo National Hospital (Hokkaido Medical Center) Department of Cardiovascular Medicine
Outcome results
None listed