Study design for control of HEART rate in inFant and child tachyarrhythmia with heart failure Using Landiolol (HEARTFUL): A prospective, multicenter, uncontrolled clinical trial. Issue 3 (September 2017)

• Record Type: Journal Article
• Authors: Sumitomo, Naokata; Horigome, Hitoshi; Miura, Masaru; Ono, Hiroshi; Ueda, Hideaki; Takigiku, Kiyohiro; Yoshimoto, Jun; Ohashi, Naoki; Suzuki, Tsugutoshi; Sagawa, Koichi; Ushinohama, Hiroya; Takahashi, Kazuhiro; Miyazaki, Aya; Sakaguchi, Heima; Iwamoto, Mari; Takamuro, Motoki; Tokunaga, Chiho; Nagano, Tetsuji
• Is Part Of: Journal of cardiology. Volume 70:Issue 3(2017:Sep.)
• Page Start: 232
• Page End: 237
• Publication Date: 2017-09
• Subjects: β-Blocker -- Heart failure -- Landiolol -- Pediatric tachyarrhythmia; Cardiology -- Periodicals; 616.12
• DOI: 10.1016/j.jjcc.2016.12.002
• Languages: English
• ISSNs: 0914-5087

Abstract

Abstract: Background: Persistent tachycardia in pediatric patients after congenital heart surgery further deteriorates their hemodynamic condition, and may become fatal. Therefore, immediate control of the tachycardia is mandatory in these patients. For this purpose, quick-acting, short-acting, titratable intravenous agents are required. However, there are no agents with such characteristics among the drugs approved for control of pediatric arrhythmias in Japan, and thus novel and effective medications for these patients are awaited. Landiolol, an ultrashort-acting β-blocker, was approved in 2013 for tachyarrhythmias in adult patients with heart failure. However, its efficacy and safety in pediatric patients remain unclear. The aim of this prospective, multicenter, open-label phase IIb/III study is to investigate the efficacy and safety of landiolol in pediatric patients with tachyarrhythmias as well as heart failure. Methods: Eligible patients are aged ≥ 3 months and <15 years, and have tachyarrhythmia (atrial fibrillation, atrial flutter, supraventricular tachycardia) as well as heart failure. The primary endpoint of the study is ≥20% reduction from baseline heart rate or return to normal sinus rhythm within 2 h after starting intravenous administration of landiolol. Patients will receive intravenous infusion of landiolol, starting at 1 μg/kg/min. The dose will be increased by 1 μg/kg/min every 15–20 min until the tachycardia rate has decreased by >20% or tachycardia has terminated, and the dose will then be maintained or further increased depending on the patient's condition. The study was started in April 2015 and will end within a few years. Conclusions: The study was designed and designated the "HEARTFUL study" in the hope of establishing a basis for control of HEART rate in inFant and child tachyarrhythmia Using Landiolol in children with heart failure.