Control of Heart Rate in Infant and Child Tachyarrhythmia With Reduced Cardiac Function Using Landiolol (HEARTFUL)　- Results of a Prospective, Multicenter, Uncontrolled Clinical Study.

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.

• Authors: Koichi Sagawa, Tsugutoshi Suzuki, Kohta Takei, Masaru Miura, Hideaki Ueda, Hitoshi Horigome, Hiroshi Ono, Naoki Ohashi, Seiichi Sato, Hideo Fukunaga, Hisaaki Aoki, Aya Miyazaki, Heima Sakaguchi, Eiichiro Morishima, Kaori Oki, Naokata Sumitomo
• Journal: Circulation journal : official journal of the Japanese Circulation Society (Circ J) Vol. 87 Issue 1 Pg. 130-138 (12 23 2022) ISSN: 1347-4820 [Electronic] Japan
• PMID: 35979562 (Publication Type: Multicenter Study, Journal Article)

Chemical References

• landiolol
• Urea
• Adrenergic beta-Antagonists

Topics

• Humans
• Child
• Infant
• Heart Rate
• Prospective Studies
• Tachycardia (drug therapy)
• Atrial Fibrillation
• Urea (adverse effects)
• Hypotension
• Adrenergic beta-Antagonists (adverse effects)