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

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2017
INTERVENTION: oral administration of dantrolene or placebo administration period is for 2 years,3 times oral administration a day 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. 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 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.
Epistemonikos ID: 7c1b696aa9b5b14fc72be19d46e49061313219d0
First added on: Aug 23, 2024