Unique ID issued by UMIN | UMIN000000548 |
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Receipt number | R000000665 |
Scientific Title | Assessment of Beta-Blocker Treatment in Japanese Patients with Chronic Heart Failure |
Date of disclosure of the study information | 2006/12/13 |
Last modified on | 2009/11/05 14:37:39 |
Assessment of Beta-Blocker Treatment in Japanese Patients with Chronic Heart Failure
J-CHF
Assessment of Beta-Blocker Treatment in Japanese Patients with Chronic Heart Failure
J-CHF
Japan |
Chronic heart failure
Cardiology |
Others
YES
The objective is to determine the optimum dose of the beta-blocker, carvedilol by comparing the efficacy and safety of 3 doses in patients with chronic heart failure from systolic dysfunction, to investigate the background factors of responders and non-responders, and to establish a method for individualized treatment employing the drug beta-blocker.
Safety,Efficacy
a composite of cardiovascular death and unplanned admission to hospital for heart failure
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.
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
Active
3
Treatment
Medicine |
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.
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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.
480
1st name | |
Middle name | |
Last name | Masatsugu Hori |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka Medical Center for Cancer and Cardiovascular Diseases
Nakamichi 1-3-3, Higashinariku, Osaka-city
1st name | |
Middle name | |
Last name | Hiroshi Okamoto |
Nishi Sapporo National Hospital (Hokkaido Medical Center)
Department of Cardiovascular Medicine
Yamanote 5-7-1-1, Nishiku, Sapporo
011-622-7720
http://poppy.ac/j-chf/
j-chf@nsp.hosp.go.jp
J-CHF Study Group
Japan Heart Foundation
Non profit foundation
NO
2006 | Year | 12 | Month | 13 | Day |
Unpublished
No longer recruiting
2003 | Year | 06 | Month | 23 | Day |
2003 | Year | 07 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2006 | Year | 12 | Month | 13 | Day |
2009 | Year | 11 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000665
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