Koichi Sagawa1, Tsugutoshi Suzuki2, Kohta Takei3, Masaru Miura4, Hideaki Ueda5, Hitoshi Horigome6, Hiroshi Ono7, Naoki Ohashi8, Seiichi Sato9, Hideo Fukunaga10, Hisaaki Aoki11, Aya Miyazaki12, Heima Sakaguchi13, Eiichiro Morishima14, Kaori Oki15, Naokata Sumitomo16. 1. Department of Pediatric Cardiology, Cardiovascular Center, Fukuoka Children's Hospital. 2. Department of Pediatric Electrophysiology, Osaka City General Hospital. 3. Department of Pediatric Cardiology, Nagano Children's Hospital. 4. Division of Cardiology, Tokyo Metropolitan Children's Medical Center. 5. Department of Cardiology, Kanagawa Children's Medical Center. 6. Department of Child Health, Faculty of Medicine, University of Tsukuba. 7. Division of Cardiology, National Center for Child Health and Development. 8. Department of Pediatric Cardiology, Japan Community Healthcare Organization Chukyo Hospital. 9. Department of Pediatric Cardiology, Okinawa Prefectural Nanbu Medical Center & Children's Medical Center. 10. Department of Pediatrics, Juntendo University Faculty of Medicine. 11. Department of Pediatric Cardiology, Osaka Women's and Children's Hospital. 12. Division of Congenital Heart Disease, Department of Transition Medicine, Shizuoka General Hospital. 13. Department of Pediatric Cardiology, National Cerebral and Cardiovascular Center. 14. Department of Statistical Analysis, Ono Pharmaceutical Co., Ltd. 15. Clinical Development Planning, Ono Pharmaceutical Co., Ltd. 16. Department of Pediatric Cardiology, Saitama Medical University International Medical Center.
Abstract
BACKGROUND: The prospective Control of HEART rate in inFant and child tachyarrhythmia with reduced cardiac function Using Landiolol (HEARTFUL) study investigated the effectiveness and safety of landiolol, a short-acting β1 selective blocker, in children.Methods and Results: Twenty-five inpatients aged ≥3 months to <15 years who developed supraventricular tachyarrhythmias (atrial fibrillation, atrial flutter, supraventricular tachycardia, and inappropriate sinus tachycardia) were treated with landiolol. The primary endpoint, the percent of patients with a reduction in heart rate ≥20% from the initial rate of tachycardia, or termination of tachycardia at 2 h after starting landiolol, was achieved in 12/25 patients (48.0%; 95% CI 28.4-67.6), which exceeded the predetermined threshold (38.0%). At 2 h after starting landiolol administration, heart rate had decreased by ≥20% in 45.8% (11/24) and recovery to sinus rhythm was achieved in 40.0% (6/15) of the patients. Adverse reactions (ARs) occurred in 24.0% (6/25) of patients, and the study was discontinued in 4.0% (1/25) of the patients; however, none of these ARs were considered serious. The most common AR was hypotension (20.0% [5/25] of patients). CONCLUSIONS: The HEARTFUL study has demonstrated the efficacy of landiolol, by reducing heart rate or terminating tachycardia, in pediatric patients with supraventricular tachyarrhythmias. Although serious ARs and concerns were not identified in this study, physicians should be always cautious of circulatory collapse due to hypotension.
BACKGROUND: The prospective Control of HEART rate in inFant and child tachyarrhythmia with reduced cardiac function Using Landiolol (HEARTFUL) study investigated the effectiveness and safety of landiolol, a short-acting β1 selective blocker, in children.Methods and Results: Twenty-five inpatients aged ≥3 months to <15 years who developed supraventricular tachyarrhythmias (atrial fibrillation, atrial flutter, supraventricular tachycardia, and inappropriate sinus tachycardia) were treated with landiolol. The primary endpoint, the percent of patients with a reduction in heart rate ≥20% from the initial rate of tachycardia, or termination of tachycardia at 2 h after starting landiolol, was achieved in 12/25 patients (48.0%; 95% CI 28.4-67.6), which exceeded the predetermined threshold (38.0%). At 2 h after starting landiolol administration, heart rate had decreased by ≥20% in 45.8% (11/24) and recovery to sinus rhythm was achieved in 40.0% (6/15) of the patients. Adverse reactions (ARs) occurred in 24.0% (6/25) of patients, and the study was discontinued in 4.0% (1/25) of the patients; however, none of these ARs were considered serious. The most common AR was hypotension (20.0% [5/25] of patients). CONCLUSIONS: The HEARTFUL study has demonstrated the efficacy of landiolol, by reducing heart rate or terminating tachycardia, in pediatric patients with supraventricular tachyarrhythmias. Although serious ARs and concerns were not identified in this study, physicians should be always cautious of circulatory collapse due to hypotension.