SHO-IN Trial

JRCT ID: jRCTs061180059

Registered date:18/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with chronic heart failure who are at least 20 years, New Tork Heart Association (NYHA) cla
• Date of first enrollment: 08/12/2017
• Target sample size: 300
• Study type: Interventional

Intervention(s)

After obtaining informed consent, patients were randomized and divided into two groups in a double-blind fashion; dantrolene group (N=150)and placebo group (N=150).
These drugs are administrated for 96 weeks

Outcome(s)

• Primary Outcome: 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
• Secondary Outcome: All-cause admission, admission due to cardiovascular events, admission due to exacerbation of heart failure, admission due to myocardial infarction, admission due to lethal arrhythmia, All-cause death, death due to cardiovascular events, death due to exacerbation of heart failure, death due to myocardial infarction, death due to lethal arrhythmia, death due to other cardiovascular events, death due to

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 JC S, 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 (patients receiving angiotensin receptor-neprilysin inhibitor (ARNI) are required to have NT-ProBNP>=600pg/mL regardless of BNP value)
#if they had been hospitalized for heart failure within the previous 12 months, BNP level of at least 100pg/ml (patients receiving ARNI are required to have NT-ProBNP>=400 pg/mL regardless of BNP value)
#if they had had VT or VF within the previous 12 months.

Exclude criteria

1)patients with severe cardiac dysfunction (NYHA IV): eg. during administration of intraveno us 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 implanta CRTD.
14)Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 monthsprior 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.

Related Information

• Primary Sponsor: Kobayashi Shigeki
• Secondary ID(s): UMIN000028766