UMIN-CTR Clinical Trial

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

Contact us.