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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000318
Receipt No. R000000411
Scientific Title Japanese Diastolic Heart Failure Study
Date of disclosure of the study information 2006/02/01
Last modified on 2016/05/05

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Basic information
Public title Japanese Diastolic Heart Failure Study
Acronym J-DHF
Scientific Title Japanese Diastolic Heart Failure Study
Scientific Title:Acronym J-DHF
Region
Japan

Condition
Condition Diastolic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to assess effects beta-blocker in patients with diastolic heart failure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes a composite of cardiovascular death and unplanned admission to hospital for congestive heart failure
Key secondary outcomes all cause mortality; worsening of the symptoms (that is defined by either a decrease by 1 Mets or over in the SAS questionnaire score or an increase by I class or over in the NYHA functional class for at least 3 months as compared with the baseline); an increase in brain natriuretic peptide (BNP) by 30% or over of the value at the randomization in patients with BNP of 200 pg/ml or over at the randomization; unplanned admission to hospital for congestive heart failure, or a need for modification of the treatment for heart failure (changes in oral medicine for at least one month or addition of intravenous inotropes for at least 4 hours)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment without beta-blocker.
Until the end of this study,
Interventions/Control_2 Treatment with beta- blocker
Until the end of this study
Interventions/Control_3
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

Not applicable
Gender Male and Female
Key inclusion criteria 1, Clinical diagnosis of heart failure based on a slight modification the Framingham criteria as previously described1 within 12 months before the entry.
2, Documentation of LV ejection fraction > 40% when diagnosed as heart failure
3, No change in baseline therapy and symptoms of heart failure within a month
Key exclusion criteria Current symptomatic hypotension
Hypertension that has not been controlled to the satisfaction of the investigator by drugs other than beta-blocker
Hemodynamically significant (in the investigators opinion) LV outflow tract obstruction (due to either aortic stenosis or ventricular hypertrophy) or mitral valve stenosis
Important aortic or mitral regurgitation in the investigators opinion
Heart rate < 50 bpm
Second or third degree heart block without permanent pacemaker in situ.
Acute coronary syndrome
Arrhythmogenic right ventricular cardiomyopathy
Primary pulmonary hypertension or pulmonary hypertension not due to LV dysfunction
Serious cerebrovascular disease
Acute myocardial infarction within the last 3 months
Patients who require intravenous inotropes
Cerebrovascular accident within the last 6 months
Percutaneous coronary intervention or open heart surgery within the last 3 months
On the waiting list for percutaneous coronary intervention or open heart surgery
Serum creatinine > 3.0 mg/dl or creatinine clearance with 30 ml/min or less
Known bilateral renal artery stenosis
Serum potassium > 5.5 mEq/l
Serious liver disease
Prescription of beta-blocker within a month, or a history of a life-threatening adverse event induced by beta-blocker
Any change in cardiovascular drug therapy within a month prior to randomization
History of chronic obstructive pulmonary disease or restrictive lung disease
Diabetes mellitus that has not been controlled to the satisfaction of the investigator
History of any life-threatening noncardiac disease (eg, cancer) within 5 years
Other diseases likely to cause death or serious disability within a year
Patients unable to walk without personal aid
Arteriosclerosis obliterans with Fontaine grade II or more.
Severe anemia (hemoglobin with 6.0 g/dl or less)
Uncontrolled thyroid dysfunction
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatsugu Hori
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita 565-0871, Japan
TEL 06-6879-5111
Email j-dhf@medone.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Yamamoto
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita 565-0871, Japan
TEL 06-6879-5111
Homepage URL http://poppy.ac/j-dhf/
Email j-dhf@medone.med.osaka-u.ac.jp

Sponsor
Institute J-DHF Study group
Institute
Department

Funding Source
Organization the Research Grant for Cardiovascular Diseases (15C-2)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

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 大阪大学医学部付属病院他

Other administrative information
Date of disclosure of the study information
2006 Year 02 Month 01 Day

Related information
URL releasing protocol http://poppy.ac/j-dhf/
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The results were published in Eur J Heart Fail 2013;15:110-8 and J Cardiol 2014;63:424-31.
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 Completed
Date of protocol fixation
2003 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2004 Year 05 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 01 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 02 Month 01 Day
Last modified on
2016 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000411

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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