Patients with chronic heart failure who are at least 20 years, New Tork Heart Association (NYHA) class II and III, and LVEF<
Conditions
Interventions
oral administration of dantrolene or placebo
administration period is for 2 years,3 times oral administration a day
Sponsors
Yamaguchi University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShigeki Kobayashi
Yamaguchi University Graduate School of Medicine Division of Cardiology
Outcome results
None listed