UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter randamized study for evaluating the effect of dantrolene aganst heart failure and arrhythmia
Title of the study (Brief title)	Dantrolene heart failure study
Region	Japan

Condition
Condition	heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of dantrolene aganst heart failure and arrhythmia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	left ventricular ejection fraction, ocurence of arrhythmia
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	dantrolene treatment/non-dantrolene treatment
Interventions/Control_2	dantrolene treatment for 2 years
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Age: from 20 years old to 85 years old 2)Heart disease with/without arrhythmia 3)Patients receive the treatment according to AHA/ACC heart failure guideline 4)Patients gave acceptance for the enrollment to this study 5)in-patients and out-patients can be included in the present study
Key exclusion criteria	1)severe COPD 2)GM 3)severe liver dydfunction 4)ileus
Target sample size	100

Research contact person
Name of lead principal investigator	Shigeki Kobayashi
Organization	Yamaguchi University Graduate School of Medicine
Division name	Division of Cardiology
Address	1-1-1 Minamikogushi, Ube, Yamaguchi, 755-8505, Japan
TEL	0836-22-2248
Email	skoba@yamaguchi-u.ac.jp

Public contact
Name of contact person	Shigeki Kobayashi
Organization	Yamaguchi University Hospital
Division name	Division of Cardiology
Address	1-1-1 Minamikogushi, Ube, Yamaguchi, 755-8505, Japan
TEL	0836-22-2248
Homepage URL
Email	skoba@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	The ministry of education in Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 06 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 26 Day
Anticipated trial start date	2016 Year 06 Month 24 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 06 Month 15 Day
Last modified on	2016 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025386