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 (SHO-IN trial): rationale and design.
Dantrolene
Heart failure
Ryanodine receptor
Ventricular arrhythmia
Journal
Journal of cardiology
ISSN: 1876-4738
Titre abrégé: J Cardiol
Pays: Netherlands
ID NLM: 8804703
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
21
06
2019
revised:
14
08
2019
accepted:
26
08
2019
pubmed:
24
12
2019
medline:
28
1
2021
entrez:
24
12
2019
Statut:
ppublish
Résumé
Leakage of Ca Patients with chronic heart failure who had functional status of New York Heart Association class II and III and a left ventricular ejection fraction <40% were treated according to the Japanese Circulation Society, the European Society of Cardiology, and the American Heart Association/the American College of Cardiology guidelines for diagnosis and treatment of acute and chronic heart failure. Patients were randomized and divided into two groups in a double-blind fashion: dantrolene group and placebo group (target sample size: 300 cases). These drugs were administered for 96 weeks. The primary endpoint is cardiovascular death, first hospitalization for exacerbation of heart failure, or lethal arrhythmia [ventricular tachycardia (VT) storm, sustained VT, ventricular fibrillation] for 2 years after starting administration of dantrolene 1 cap (25mg) three times daily (if not tolerable, two times daily) or matching placebo. This paper presents the rationale and trial design of the study. Recruitment for the study started on 8 December 2017. The results of this trial will clarify the efficacy and safety of dantrolene for ventricular arrhythmia, as well as mortality and morbidity in patients with chronic heart failure and reduced ejection fraction during guideline-directed medical treatment.
Sections du résumé
BACKGROUND
Leakage of Ca
METHODS
Patients with chronic heart failure who had functional status of New York Heart Association class II and III and a left ventricular ejection fraction <40% were treated according to the Japanese Circulation Society, the European Society of Cardiology, and the American Heart Association/the American College of Cardiology guidelines for diagnosis and treatment of acute and chronic heart failure. Patients were randomized and divided into two groups in a double-blind fashion: dantrolene group and placebo group (target sample size: 300 cases). These drugs were administered for 96 weeks. The primary endpoint is cardiovascular death, first hospitalization for exacerbation of heart failure, or lethal arrhythmia [ventricular tachycardia (VT) storm, sustained VT, ventricular fibrillation] for 2 years after starting administration of dantrolene 1 cap (25mg) three times daily (if not tolerable, two times daily) or matching placebo.
RESULTS
This paper presents the rationale and trial design of the study. Recruitment for the study started on 8 December 2017.
CONCLUSIONS
The results of this trial will clarify the efficacy and safety of dantrolene for ventricular arrhythmia, as well as mortality and morbidity in patients with chronic heart failure and reduced ejection fraction during guideline-directed medical treatment.
Identifiants
pubmed: 31866190
pii: S0914-5087(19)30282-5
doi: 10.1016/j.jjcc.2019.08.020
pii:
doi:
Substances chimiques
Dantrolene
F64QU97QCR
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
454-461Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2019 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.