UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028766 |
|---|---|
| Receipt number | 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 14:43:21 |
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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
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
sho-in@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032916
