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

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 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


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

Value
https://center6.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