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

Sumitomo, Naokata; Horigome, Hitoshi; Miura, Masaru; Ono, Hiroshi; Ueda, Hideaki; Takigiku, Kiyohiro; Ye, Jun; Ohashi, Naoki; Suzuki, Tsugutoshi; Sagawa, Koichi; Ushinohama, Hiroya; Takahashi, Kazuhiro; Miyazaki, Aya; Sakaguchi, Heima; Iwamoto, Mari; Takamuro, Motoki; Tokunaga, Chiho; Nagano, Tetsuji

doi:10.1016/j.jjcc.2016.12.002

Cited by 8 publications

(10 citation statements)

References 23 publications

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“…Landiolol has been shown to be safe and effective for the treatment of atrial arrhythmia in adults . This case showed that cardioversion did not cause suppression with stimulation of the arrhythmogenic substrates of atrial tachyarrhythmia.…”

Section: Discussionmentioning

confidence: 76%

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Efficacy and safety of cardioversion with continuous landiolol infusion for atrial tachyarrhythmia in an inflammatory state caused by volvulus in a child with TARP syndrome and postoperative tetralogy of Fallot

Miyamoto

Ishii

Fukuda

et al. 2018

Journal of Arrhythmia

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A 2‐year‐old boy was diagnosed with TARP syndrome and underwent surgery for tetralogy of Fallot. He developed fever and had an acute abdomen. After 12 hours, atrial tachyarrhythmia (300 beats/min [bpm]) occurred. After nine administration of adenosine and two cardioversions, it relapsed promptly. Landiolol (10 μg/kg/min) was administered until the heart rate decreased to 270 bpm, and cardioversion was performed until sinus rhythm was normal. Exploratory laparotomy revealed small bowel volvulus. Systemic inflammation causing an acute abdomen may be associated with atrial tachyarrhythmia in postoperative tetralogy of Fallot. We speculated that landiolol lowered the defibrillation threshold of the atrium.

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Section: Discussionmentioning

confidence: 76%

“…Although landiolol, an ultrashort‐acting β‐blocker, is effective for atrial tachyarrhythmia in adult patients, its efficacy in pediatric patients is unclear . Here, we report the effectiveness of landiolol for atrial tachyarrhythmia in a 2‐year‐old boy with tetralogy of Fallot and TARP syndrome.…”

Section: Introductionmentioning

confidence: 91%

Efficacy and safety of cardioversion with continuous landiolol infusion for atrial tachyarrhythmia in an inflammatory state caused by volvulus in a child with TARP syndrome and postoperative tetralogy of Fallot

Miyamoto

Ishii

Fukuda

et al. 2018

Journal of Arrhythmia

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“…86 Approximately 80% patients were converted to regular sinus rhythm within 24 hours after starting administration of landiolol and 90% patients had atrioventricular sequential pacing to maintain appropriate heart rate under landiolol suppression of the junctional heart rate. There is one RCT conducted by Sumitomo et al named the HEARTFUL study in which landiolol was administered to prevent tachyarrhythmia in a dose starting from 1 μg/kg/min to achieve a 20% reduction of HR in patients aged from 3 months to 15 years old patients with heart failure 87 (Table 4).…”

Section: Role Of Prophylactic Landiolol In Pediatric Patientsmentioning

confidence: 99%

<p>Evaluating the Therapeutic Efficacy and Safety of Landiolol Hydrochloride for Management of Arrhythmia in Critical Settings: Review of the Literature</p>

Matsuishi¹,

Mathis²,

Shimojo³

et al. 2020

VHRM

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Background: Landiolol hydrochloride, a highly cardio-selective beta-1 blocker with an ultra-short-acting half-life of 4 minutes, was originally approved by Japan for treatment of intraoperative tachyarrhythmias. This review aims to provide an integrated overview of the current state of knowledge of landiolol hydrochloride in the management of arrhythmia in critical settings. Methods: We searched MEDLINE, EMBASE, and the Cochrane Library to retrieve relevant articles with a total of 65 records identified. Results: The high β1 selectivity (β1/β2 ratio of 255:1) of landiolol causes a more rapid heart rate (HR) decrease compared to esmolol while avoiding decreases in mean arterial blood pressure. Recently, it has been found useful in left ventricular dysfunction patients and fatal arrhythmia requiring emergency treatment. Recent random clinical trials (RCT) have revealed therapeutic and prophylactic effects on arrhythmia, and very low-dose landiolol might be effective for preventing postoperative atrial fibrillation (POAF) and sinus tachycardia. Likewise, landiolol is an optimal choice for perioperative tachycardia treatment during cardiac surgery. The high β1 selectivity of landiolol is useful in heart failure patients as a first-line therapy for tachycardia and arrhythmia as it avoids the typical depression of cardiac function seen in other β-blockers. Application in cardiac injury after percutaneous coronary intervention (PCI), protection for vital organs (lung, kidney, etc.) during sepsis, and stabilizing hemodynamics in pediatric patients are becoming the new frontier of landiolol use. Conclusion: Landiolol is useful as a first-line therapy for the prevention of POAF after cardiac/non-cardiac surgery, fatal arrhythmias in heart failure patients and during PCI. Moreover, the potential therapeutic effect of landiolol for sepsis in pediatric patients is currently being explored. As positive RCT results continue to be published, new clinical uses and further clinical studies in various settings by cardiologists, intensivists and pediatric cardiologists are being conducted.

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“…The design of the HEARTFUL study is comprehensively described in our previous report. 26 The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice, and was approved by the Institutional Review Boards at 15 participating institutions. The study was registered in the JapicCTI database (JapicCTI-152911; http://www.japic.…”

Section: Ethicsmentioning

confidence: 99%

“…Other eligibility criteria are described in our prior report. 26 Written informed consent was obtained from all of the parents/guardians, or from the patient if considered appropriate.…”

mentioning

confidence: 99%

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

Sagawa

Suzuki

Takei

et al. 2022

Circ J

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macological therapy, non-pharmacological treatments, such as catheter ablation or implantation of a cardioverter defibrillator, are an option for adult patients. 3,4 However, non-pharmacological approaches are sometimes difficult in some types of CHD, or after surgical procedures for anatomical reasons in children. 2,5 Amiodarone and nifeka-V arious tachyarrhythmias may occur after surgical repair of congenital heart disease (CHD) and they may be potentially fatal. 1,2 Following onset, emergency therapy to control and terminate the tachycardia, and to prevent circulatory deteriorations, is usually mandatory. In patients with tachyarrhythmia resistant to phar-

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

Abstract: 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.

Cited by 8 publications

References 23 publications

Efficacy and safety of cardioversion with continuous landiolol infusion for atrial tachyarrhythmia in an inflammatory state caused by volvulus in a child with TARP syndrome and postoperative tetralogy of Fallot

Efficacy and safety of cardioversion with continuous landiolol infusion for atrial tachyarrhythmia in an inflammatory state caused by volvulus in a child with TARP syndrome and postoperative tetralogy of Fallot

<p>Evaluating the Therapeutic Efficacy and Safety of Landiolol Hydrochloride for Management of Arrhythmia in Critical Settings: Review of the Literature</p>

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

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

Abstract: 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.

Cited by 8 publications

References 23 publications

Efficacy and safety of cardioversion with continuous landiolol infusion for atrial tachyarrhythmia in an inflammatory state caused by volvulus in a child with TARP syndrome and postoperative tetralogy of Fallot

Efficacy and safety of cardioversion with continuous landiolol infusion for atrial tachyarrhythmia in an inflammatory state caused by volvulus in a child with TARP syndrome and postoperative tetralogy of Fallot

<p>Evaluating the Therapeutic Efficacy and Safety of Landiolol Hydrochloride for Management of Arrhythmia in Critical Settings: Review of the Literature</p>

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

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