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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Diastolic heart failure | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Treatment without beta-blocker.
Until the end of this study, |
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Interventions/Control_2 | Treatment with beta- blocker
Until the end of this study |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |