UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000318 |
|---|---|
| Receipt number | R000000411 |
| Scientific Title | Japanese Diastolic Heart Failure Study |
| Date of disclosure of the study information | 2006/02/01 |
| Last modified on | 2016/05/05 09:31:31 |
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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
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/
j-dhf@medone.med.osaka-u.ac.jp
Sponsor or person
Institute
J-DHF Study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000411
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| Registered date | File name |
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| Registered date | File name |
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