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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000548
Receipt No. 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

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Basic information
Public title Assessment of Beta-Blocker Treatment in Japanese Patients with Chronic Heart Failure
Acronym J-CHF
Scientific Title Assessment of Beta-Blocker Treatment in Japanese Patients with Chronic Heart Failure
Scientific Title:Acronym J-CHF
Region
Japan

Condition
Condition Chronic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes a composite of cardiovascular death and unplanned admission to hospital for heart failure
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_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.
Interventions/Control_3 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.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key 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.
Key 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.
Target sample size 480

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatsugu Hori
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Osaka Medical Center for Cancer and Cardiovascular Diseases
Zip code
Address Nakamichi 1-3-3, Higashinariku, Osaka-city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Okamoto
Organization Nishi Sapporo National Hospital (Hokkaido Medical Center)
Division name Department of Cardiovascular Medicine
Zip code
Address Yamanote 5-7-1-1, Nishiku, Sapporo
TEL 011-622-7720
Homepage URL http://poppy.ac/j-chf/
Email j-chf@nsp.hosp.go.jp

Sponsor
Institute J-CHF Study Group
Institute
Department

Funding Source
Organization Japan Heart Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 12 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2003 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2003 Year 07 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 12 Month 13 Day
Last modified on
2009 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000665

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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