UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Benidipine, a Long-acting Dihydropyridine Calcium Channel Blocker, for Dilated Cardiomyopathy Patients with Coronary Vasospasm
Title of the study (Brief title)	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	Hiroaki Shimokawa
Organization	Tohoku University Graduate School of Medicine
Division name	Cardiovascular Medicine
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7153
Email	shimo@cardio.med.tohoku.ac.jp

Public contact
Name of contact person	Katsuya Kozu
Organization	Tohoku University Graduate School of Medicine
Division name	Cardiovascular Medicine
Address	1-1, Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7153
Homepage URL
Email	kozu.k@cardio.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 06 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025265