UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021961 |
|---|---|
| Receipt number | R000025265 |
| Scientific Title | Efficacy of Benidipine, a Long-acting Dihydropyridine Calcium Channel Blocker, for Dilated Cardiomyopathy Patients with Coronary Vasospasm |
| Date of disclosure of the study information | 2016/04/20 |
| Last modified on | 2017/04/25 10:56:52 |
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Basic information
Public title
Efficacy of Benidipine, a Long-acting Dihydropyridine Calcium Channel Blocker, for Dilated Cardiomyopathy Patients with Coronary Vasospasm
Acronym
Efficacy of Benidipine for DCM Patients with Coronary Vasospasm
Scientific Title
Efficacy of Benidipine, a Long-acting Dihydropyridine Calcium Channel Blocker, for Dilated Cardiomyopathy Patients with Coronary Vasospasm
Scientific Title:Acronym
Efficacy of Benidipine for DCM Patients with Coronary Vasospasm
Region
| Japan |
Condition
Condition
dilated cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the role of coronary vasospasm in the pathogenesis of dilated cardiomyopathy, and to evaluate the efficacy of calcium channel blocker on cardiac function for the subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Ejection Fraction at 6 months after the initiation of the treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Benidipine, twice a day, 2mg to 8mg per day, for 6 months
Interventions/Control_2
no intervention
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
Patients who are diagnosed as dilated cardiomyopathy definitely or suspiciously and meet following criteria;
1) Ejection Fraction <=40% and >=20%,
2) without valvular disease and significant stenosis or obstruction in coronary arteries, and who are excluded secondary cardiomyopathy by myocardial biopsy,
3) who are in stable status with symptoms of NYHA 1 to 3 within 3 months before intervention
Key exclusion criteria
1) Patients who have ischemic heart disease, valvular disease, acute myocarditis, and secondary cardiomyopathy
2) Patients who have been taking calcium channel blocker
3) Patients in unstable status with symptoms of NYHA 4
4) Patients having serious liver dysfunction or having serious renal dysfunction requiring hemodialysis
5) Patients who are intolerant to dihydropyridine calcium channel blocker
6) Patients with a contraindication to dihydropyridine calcium channel blocker
7) Patients who are pregnant
8) Patients who did not consent to the trial
9) Patients who were considered as inappropriate candidates for the trial by phsicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Shimokawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7153
shimo@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuya Kozu |
Organization
Tohoku University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7153
Homepage URL
kozu.k@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 18 | Day |
Last modified on
| 2017 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025265
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
