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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028766
Receipt No. R000032916
Scientific Title A multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of dantrolene on ventricular arrhythmia as well as mortality and morbidity in patients with chronic heart failure and reduced ejection fraction
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/22

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Basic information
Public title A multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of dantrolene on ventricular arrhythmia as well as mortality and morbidity in patients with chronic heart failure and reduced ejection fraction
Acronym SHO-IN TRIAL
Scientific Title A multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of dantrolene on ventricular arrhythmia as well as mortality and morbidity in patients with chronic heart failure and reduced ejection fraction
Scientific Title:Acronym SHO-IN TRIAL
Region
Japan

Condition
Condition Patients with chronic heart failure who are at least 20 years, New Tork Heart Association (NYHA) class II and III, and LVEF<40% during treatment according to JCS and/or ACC/AHA and/or ESC heart failure guidelines.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of dantrolene against heart failure and arrhythmia in patients with chronic heart failure (NYHA II-III) and reduced ejection fraction in a multicenter, randomized, double-blind, controlled study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes a composite of death (cardiovascular and non-cardiovasclar death), lethal arrhythmia (ventricular tachycardia(VT) storm, sustained VT, ventricular fibrillation)or a first hospitalization for exacerbation of heart failure 2 years after starting administration of dantrolene or placebo
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 oral administration of dantrolene or placebo
Interventions/Control_2 administration period is for 2 years,3 times oral administration a day
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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1)20 years and older
2)eligible for male and female
3)eligible for in-patients and out-patients
4) patients who fulfill all the following criteria.
a) patients who receive treatment according JCS, ESC, AHA/ACC heart failure guidelines
b)NYHA II and III
c)LVEF is less than 40%
d)BNP levels
#ordinary, BNP level of at least 150pg/ml
#if they had been hospitalized for heart failure within the previous 12 months, BNP level of at least 100pg/ml
#if they had had VT or VF within the previous 12 months.

Key exclusion criteria 1)patients with severe cardiac dysfunction (NYHA IV): eg. during administration of intravenous catecholamine and/or PDE III inhibitor and/or vasodilator and/or diuretics.
2)patients wit COPD and severe dysfunction of repiratory funcion
3)patient diagnosed with myasthenia gravis
4)patients with severe liver dysfunction
5)patients with ileus
6)patients who could not receive oral meadication
7)during pregnancy or lactation
8)history of allergy and hypersensitivity for dantrolene
9)History of )Acute coronary syndrome, stroke, transient ischemic attack within the 3 months prior obtaining informed concent.
10) cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to obtaining informed consent.
11)Coronary or carotid artery disease likely to require surgical or percutaneous intervention within 2 years after starting oral administration of dantrolene or placebo.
12)Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the6 months after obtaining informed consent.
13)Implantation of a cardiac resynchronization therapy device (CRTD) within 3 months prior obtaining informed consent or intent to implant a CRTD.
14)Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to obtaining informed consent.
15)History of heart transplant or on a transplant list or with left ventricular assistance device (LVAD).
16)Symptomatic bradycardia or second or third degree heart block without a pacemaker.
17)patients with severe valvular heart disease and severe HOCM
18)patients with severe inflammatory disease such as sepsis and pneumonia et al.
19)patients with active cardiac sarcoidosis
20)patients with amyloidosis
21)patients with Fabry disease
22)dialysis patients
23)cancer patients
24)patients who primary investigator and investigators consider as unsuitable for the present study.

Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Yano
Organization Yamaguchi University Graduate School of Medicine
Division name Division of Cardiology
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi, 755-8505, Japan
TEL 0836-22-2248
Email yanoma@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Kobayashi
Organization Yamaguchi University Graduate School of Medicine
Division name Division of Cardiology
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi, 755-8505, Japan
TEL 0836-22-2248
Homepage URL
Email sho-in@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine
Institute
Department

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)

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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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
2017 Year 08 Month 21 Day
Last modified on
2017 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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