Landiolol in the treatment of the intraoperative supraventricular tachycardia: a multicenter, randomized, double-blind, placebo-controlled study

Abstract Background Supraventricular tachycardia during the induction of anesthesia may carry a higher risk. Study objective The aim of this study was to evaluate efficacy and safety of intravenous landiolol in Chinese patients with intraoperative supraventricular tachycardia during anesthesia. Desi...

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Veröffentlicht in:Journal of clinical anesthesia 2015-03, Vol.27 (2), p.120-128
Hauptverfasser: Xiao, Jie, He, Ping, Zou, Qiaoqun, Zhao, Yanhua, Xue, Zhanggang, Deng, Xiaoming, Li, Shitong, Guo, Qunlian, Tao, Guocai, Yang, Tiande, Lang, Zhixun, He, Jia, Wang, Xiangrui
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container_end_page 128
container_issue 2
container_start_page 120
container_title Journal of clinical anesthesia
container_volume 27
creator Xiao, Jie
He, Ping
Zou, Qiaoqun
Zhao, Yanhua
Xue, Zhanggang
Deng, Xiaoming
Li, Shitong
Guo, Qunlian
Tao, Guocai
Yang, Tiande
Lang, Zhixun
He, Jia
Wang, Xiangrui
description Abstract Background Supraventricular tachycardia during the induction of anesthesia may carry a higher risk. Study objective The aim of this study was to evaluate efficacy and safety of intravenous landiolol in Chinese patients with intraoperative supraventricular tachycardia during anesthesia. Design A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase 2 study. Setting Eight sites of Chinese hospitals. Patients Men and women aged 18 to 70 years with the intraoperative supraventricular tachycardia (heart rate [HR], ≥ 100 beats/min) or the supraventricular tachycardia outside of the sinus tachycardia lasting more than 1 minute. Interventions Patients received landiolol or placebo—0.125 mg kg − 1 min − 1 (1 minute) loading→0.04 mg kg − 1 min − 1 (10 minutes) continuous. Measurements The proportion of patients receiving rescue medication (esmolol) when the reduction of HR did not exceed 10% after intravenous landiolol for 5 minutes. Other secondary efficacy end points include HR, blood pressure, rate pressure product, and electrocardiogram; the improvement of supraventricular tachycardia; the time it takes for the decrease of the HR to reach more than 10%; and the time it takes for the HR to reach < 100 beats/min. Main results Efficacy and safety were evaluated for 240 patients who received study drug. Lower proportions of patients received rescue medication in the landiolol group (7.63%) compared with that in the placebo group (80.33%) ( P < .0001). Suppression of HR and rate pressure product was generally more potent( P < .0001), and higher proportions of patients improved supraventricular tachycardia ( P < .0001) in the landiolol group. The most frequent adverse event was hypotension. Conclusion Intravenous landiolol (loading dose of 0.125 mg/kg) may effectively control intraoperative supraventricular tachycardia during anesthesia. It inhibited the increases in HR during the induction of anesthesia. The effect of landiolol on blood pressure was minimal without decreasing diastolic blood pressure and with the minor reduction of systolic blood pressure (ClinicalTrials.gov number, ChiCTR-TRC-12003021).
doi_str_mv 10.1016/j.jclinane.2014.07.003
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Study objective The aim of this study was to evaluate efficacy and safety of intravenous landiolol in Chinese patients with intraoperative supraventricular tachycardia during anesthesia. Design A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase 2 study. Setting Eight sites of Chinese hospitals. Patients Men and women aged 18 to 70 years with the intraoperative supraventricular tachycardia (heart rate [HR], ≥ 100 beats/min) or the supraventricular tachycardia outside of the sinus tachycardia lasting more than 1 minute. Interventions Patients received landiolol or placebo—0.125 mg kg − 1 min − 1 (1 minute) loading→0.04 mg kg − 1 min − 1 (10 minutes) continuous. Measurements The proportion of patients receiving rescue medication (esmolol) when the reduction of HR did not exceed 10% after intravenous landiolol for 5 minutes. Other secondary efficacy end points include HR, blood pressure, rate pressure product, and electrocardiogram; the improvement of supraventricular tachycardia; the time it takes for the decrease of the HR to reach more than 10%; and the time it takes for the HR to reach &lt; 100 beats/min. Main results Efficacy and safety were evaluated for 240 patients who received study drug. Lower proportions of patients received rescue medication in the landiolol group (7.63%) compared with that in the placebo group (80.33%) ( P &lt; .0001). Suppression of HR and rate pressure product was generally more potent( P &lt; .0001), and higher proportions of patients improved supraventricular tachycardia ( P &lt; .0001) in the landiolol group. The most frequent adverse event was hypotension. Conclusion Intravenous landiolol (loading dose of 0.125 mg/kg) may effectively control intraoperative supraventricular tachycardia during anesthesia. It inhibited the increases in HR during the induction of anesthesia. The effect of landiolol on blood pressure was minimal without decreasing diastolic blood pressure and with the minor reduction of systolic blood pressure (ClinicalTrials.gov number, ChiCTR-TRC-12003021).</description><identifier>ISSN: 0952-8180</identifier><identifier>EISSN: 1873-4529</identifier><identifier>DOI: 10.1016/j.jclinane.2014.07.003</identifier><identifier>PMID: 25434501</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject><![CDATA[Adrenergic beta-1 Receptor Antagonists - administration & dosage ; Adult ; Aged ; Anesthesia & Perioperative Care ; Anti-Arrhythmia Agents - administration & dosage ; Anti-Arrhythmia Agents - adverse effects ; Anti-Arrhythmia Agents - therapeutic use ; Blood Pressure - drug effects ; Cardiac arrhythmia ; Double-Blind Method ; Drug Administration Schedule ; Drug therapy ; Drug Therapy, Combination ; Efficacy ; Electrocardiography ; Esmolol ; Female ; Heart attacks ; Heart Rate - drug effects ; Humans ; Hypotension - chemically induced ; Infusions, Intravenous ; Intraoperative Complications - drug therapy ; Intraoperative Complications - physiopathology ; Intraoperative supraventricular tachycardia ; Landiolol ; Male ; Middle Aged ; Morpholines - administration & dosage ; Morpholines - adverse effects ; Morpholines - therapeutic use ; Pain Medicine ; Propanolamines - administration & dosage ; Safety ; Tachycardia, Supraventricular - drug therapy ; Tachycardia, Supraventricular - physiopathology ; Treatment Outcome ; Urea - administration & dosage ; Urea - adverse effects ; Urea - analogs & derivatives ; Urea - therapeutic use ; Young Adult]]></subject><ispartof>Journal of clinical anesthesia, 2015-03, Vol.27 (2), p.120-128</ispartof><rights>Elsevier Inc.</rights><rights>2014 Elsevier Inc.</rights><rights>Copyright © 2014 Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c451t-592e5e34b853298ecd6ff49ff7d6b81a6dd8ab5450ff6558a2f3b626ba1daf593</citedby><cites>FETCH-LOGICAL-c451t-592e5e34b853298ecd6ff49ff7d6b81a6dd8ab5450ff6558a2f3b626ba1daf593</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1661114667?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25434501$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Xiao, Jie</creatorcontrib><creatorcontrib>He, Ping</creatorcontrib><creatorcontrib>Zou, Qiaoqun</creatorcontrib><creatorcontrib>Zhao, Yanhua</creatorcontrib><creatorcontrib>Xue, Zhanggang</creatorcontrib><creatorcontrib>Deng, Xiaoming</creatorcontrib><creatorcontrib>Li, Shitong</creatorcontrib><creatorcontrib>Guo, Qunlian</creatorcontrib><creatorcontrib>Tao, Guocai</creatorcontrib><creatorcontrib>Yang, Tiande</creatorcontrib><creatorcontrib>Lang, Zhixun</creatorcontrib><creatorcontrib>He, Jia</creatorcontrib><creatorcontrib>Wang, Xiangrui</creatorcontrib><title>Landiolol in the treatment of the intraoperative supraventricular tachycardia: a multicenter, randomized, double-blind, placebo-controlled study</title><title>Journal of clinical anesthesia</title><addtitle>J Clin Anesth</addtitle><description>Abstract Background Supraventricular tachycardia during the induction of anesthesia may carry a higher risk. Study objective The aim of this study was to evaluate efficacy and safety of intravenous landiolol in Chinese patients with intraoperative supraventricular tachycardia during anesthesia. Design A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase 2 study. Setting Eight sites of Chinese hospitals. Patients Men and women aged 18 to 70 years with the intraoperative supraventricular tachycardia (heart rate [HR], ≥ 100 beats/min) or the supraventricular tachycardia outside of the sinus tachycardia lasting more than 1 minute. Interventions Patients received landiolol or placebo—0.125 mg kg − 1 min − 1 (1 minute) loading→0.04 mg kg − 1 min − 1 (10 minutes) continuous. Measurements The proportion of patients receiving rescue medication (esmolol) when the reduction of HR did not exceed 10% after intravenous landiolol for 5 minutes. Other secondary efficacy end points include HR, blood pressure, rate pressure product, and electrocardiogram; the improvement of supraventricular tachycardia; the time it takes for the decrease of the HR to reach more than 10%; and the time it takes for the HR to reach &lt; 100 beats/min. Main results Efficacy and safety were evaluated for 240 patients who received study drug. Lower proportions of patients received rescue medication in the landiolol group (7.63%) compared with that in the placebo group (80.33%) ( P &lt; .0001). Suppression of HR and rate pressure product was generally more potent( P &lt; .0001), and higher proportions of patients improved supraventricular tachycardia ( P &lt; .0001) in the landiolol group. The most frequent adverse event was hypotension. Conclusion Intravenous landiolol (loading dose of 0.125 mg/kg) may effectively control intraoperative supraventricular tachycardia during anesthesia. It inhibited the increases in HR during the induction of anesthesia. 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dosage</subject><subject>Morpholines - adverse effects</subject><subject>Morpholines - therapeutic use</subject><subject>Pain Medicine</subject><subject>Propanolamines - administration &amp; dosage</subject><subject>Safety</subject><subject>Tachycardia, Supraventricular - drug therapy</subject><subject>Tachycardia, Supraventricular - physiopathology</subject><subject>Treatment Outcome</subject><subject>Urea - administration &amp; dosage</subject><subject>Urea - adverse effects</subject><subject>Urea - analogs &amp; derivatives</subject><subject>Urea - therapeutic use</subject><subject>Young Adult</subject><issn>0952-8180</issn><issn>1873-4529</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFks9u1DAQxiMEokvhFSpLXDg0wXZiJ-GAQFX5I63EAThbjj1WHZw42M5Ky1PwyHXYFqReOFn2_ObzzHxTFBcEVwQT_nqsRuXsLGeoKCZNhdsK4_pRsSNdW5cNo_3jYod7RsuOdPiseBbjiDHOAfK0OKOsqRuGya74vZeztt55h-yM0g2gFECmCeaEvPnzYOcUpF8gyGQPgOK6BHnI8WDV6mRASaqbo5JBW_kGSTStLlmV4xAuUcjqfrK_QF8i7dfBQTnksvNtcVLB4Evls5J3DjSKadXH58UTI12EF3fnefH9w_W3q0_l_svHz1fv96VqGEkl6ykwqJuhYzXtO1CaG9P0xrSaDx2RXOtODiw3aQxnrJPU1AOnfJBES8P6-rx4ddJdgv-5QkxislGBc3mkfo2CcE4b2nWYZvTlA3T0a5hzdRtFCGk4bzPFT5QKPsYARizBTjIcBcFi80yM4t4zsXkmcCuyZznx4k5-HSbQf9PuTcrAuxMAeR4HC0FEZWFWoG0AlYT29v9_vH0gsVFWSfcDjhD_9SMiFVh83TZnWxzS5GzKcH0LJzLDbg</recordid><startdate>20150301</startdate><enddate>20150301</enddate><creator>Xiao, Jie</creator><creator>He, Ping</creator><creator>Zou, Qiaoqun</creator><creator>Zhao, Yanhua</creator><creator>Xue, Zhanggang</creator><creator>Deng, Xiaoming</creator><creator>Li, Shitong</creator><creator>Guo, Qunlian</creator><creator>Tao, Guocai</creator><creator>Yang, Tiande</creator><creator>Lang, Zhixun</creator><creator>He, Jia</creator><creator>Wang, Xiangrui</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20150301</creationdate><title>Landiolol in the treatment of the intraoperative supraventricular tachycardia: a multicenter, randomized, double-blind, placebo-controlled study</title><author>Xiao, Jie ; He, Ping ; Zou, Qiaoqun ; Zhao, Yanhua ; Xue, Zhanggang ; Deng, Xiaoming ; Li, Shitong ; Guo, Qunlian ; Tao, Guocai ; Yang, Tiande ; Lang, Zhixun ; He, Jia ; Wang, Xiangrui</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c451t-592e5e34b853298ecd6ff49ff7d6b81a6dd8ab5450ff6558a2f3b626ba1daf593</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adrenergic beta-1 Receptor Antagonists - administration &amp; dosage</topic><topic>Adult</topic><topic>Aged</topic><topic>Anesthesia &amp; Perioperative Care</topic><topic>Anti-Arrhythmia Agents - administration &amp; dosage</topic><topic>Anti-Arrhythmia Agents - adverse effects</topic><topic>Anti-Arrhythmia Agents - therapeutic use</topic><topic>Blood Pressure - drug effects</topic><topic>Cardiac arrhythmia</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Efficacy</topic><topic>Electrocardiography</topic><topic>Esmolol</topic><topic>Female</topic><topic>Heart attacks</topic><topic>Heart Rate - drug effects</topic><topic>Humans</topic><topic>Hypotension - chemically induced</topic><topic>Infusions, Intravenous</topic><topic>Intraoperative Complications - drug therapy</topic><topic>Intraoperative Complications - physiopathology</topic><topic>Intraoperative supraventricular tachycardia</topic><topic>Landiolol</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Morpholines - administration &amp; dosage</topic><topic>Morpholines - adverse effects</topic><topic>Morpholines - therapeutic use</topic><topic>Pain Medicine</topic><topic>Propanolamines - administration &amp; dosage</topic><topic>Safety</topic><topic>Tachycardia, Supraventricular - drug therapy</topic><topic>Tachycardia, Supraventricular - physiopathology</topic><topic>Treatment Outcome</topic><topic>Urea - administration &amp; dosage</topic><topic>Urea - adverse effects</topic><topic>Urea - analogs &amp; derivatives</topic><topic>Urea - therapeutic use</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Xiao, Jie</creatorcontrib><creatorcontrib>He, Ping</creatorcontrib><creatorcontrib>Zou, Qiaoqun</creatorcontrib><creatorcontrib>Zhao, Yanhua</creatorcontrib><creatorcontrib>Xue, Zhanggang</creatorcontrib><creatorcontrib>Deng, Xiaoming</creatorcontrib><creatorcontrib>Li, Shitong</creatorcontrib><creatorcontrib>Guo, Qunlian</creatorcontrib><creatorcontrib>Tao, Guocai</creatorcontrib><creatorcontrib>Yang, Tiande</creatorcontrib><creatorcontrib>Lang, Zhixun</creatorcontrib><creatorcontrib>He, Jia</creatorcontrib><creatorcontrib>Wang, Xiangrui</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical anesthesia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Xiao, Jie</au><au>He, Ping</au><au>Zou, Qiaoqun</au><au>Zhao, Yanhua</au><au>Xue, Zhanggang</au><au>Deng, Xiaoming</au><au>Li, Shitong</au><au>Guo, Qunlian</au><au>Tao, Guocai</au><au>Yang, Tiande</au><au>Lang, Zhixun</au><au>He, Jia</au><au>Wang, Xiangrui</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Landiolol in the treatment of the intraoperative supraventricular tachycardia: a multicenter, randomized, double-blind, placebo-controlled study</atitle><jtitle>Journal of clinical anesthesia</jtitle><addtitle>J Clin Anesth</addtitle><date>2015-03-01</date><risdate>2015</risdate><volume>27</volume><issue>2</issue><spage>120</spage><epage>128</epage><pages>120-128</pages><issn>0952-8180</issn><eissn>1873-4529</eissn><abstract>Abstract Background Supraventricular tachycardia during the induction of anesthesia may carry a higher risk. Study objective The aim of this study was to evaluate efficacy and safety of intravenous landiolol in Chinese patients with intraoperative supraventricular tachycardia during anesthesia. Design A randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase 2 study. Setting Eight sites of Chinese hospitals. Patients Men and women aged 18 to 70 years with the intraoperative supraventricular tachycardia (heart rate [HR], ≥ 100 beats/min) or the supraventricular tachycardia outside of the sinus tachycardia lasting more than 1 minute. Interventions Patients received landiolol or placebo—0.125 mg kg − 1 min − 1 (1 minute) loading→0.04 mg kg − 1 min − 1 (10 minutes) continuous. Measurements The proportion of patients receiving rescue medication (esmolol) when the reduction of HR did not exceed 10% after intravenous landiolol for 5 minutes. Other secondary efficacy end points include HR, blood pressure, rate pressure product, and electrocardiogram; the improvement of supraventricular tachycardia; the time it takes for the decrease of the HR to reach more than 10%; and the time it takes for the HR to reach &lt; 100 beats/min. Main results Efficacy and safety were evaluated for 240 patients who received study drug. Lower proportions of patients received rescue medication in the landiolol group (7.63%) compared with that in the placebo group (80.33%) ( P &lt; .0001). Suppression of HR and rate pressure product was generally more potent( P &lt; .0001), and higher proportions of patients improved supraventricular tachycardia ( P &lt; .0001) in the landiolol group. The most frequent adverse event was hypotension. Conclusion Intravenous landiolol (loading dose of 0.125 mg/kg) may effectively control intraoperative supraventricular tachycardia during anesthesia. It inhibited the increases in HR during the induction of anesthesia. The effect of landiolol on blood pressure was minimal without decreasing diastolic blood pressure and with the minor reduction of systolic blood pressure (ClinicalTrials.gov number, ChiCTR-TRC-12003021).</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>25434501</pmid><doi>10.1016/j.jclinane.2014.07.003</doi><tpages>9</tpages></addata></record>
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ispartof Journal of clinical anesthesia, 2015-03, Vol.27 (2), p.120-128
issn 0952-8180
1873-4529
language eng
recordid cdi_proquest_miscellaneous_1662428802
source MEDLINE; Access via ScienceDirect (Elsevier); ProQuest Central UK/Ireland
subjects Adrenergic beta-1 Receptor Antagonists - administration & dosage
Adult
Aged
Anesthesia & Perioperative Care
Anti-Arrhythmia Agents - administration & dosage
Anti-Arrhythmia Agents - adverse effects
Anti-Arrhythmia Agents - therapeutic use
Blood Pressure - drug effects
Cardiac arrhythmia
Double-Blind Method
Drug Administration Schedule
Drug therapy
Drug Therapy, Combination
Efficacy
Electrocardiography
Esmolol
Female
Heart attacks
Heart Rate - drug effects
Humans
Hypotension - chemically induced
Infusions, Intravenous
Intraoperative Complications - drug therapy
Intraoperative Complications - physiopathology
Intraoperative supraventricular tachycardia
Landiolol
Male
Middle Aged
Morpholines - administration & dosage
Morpholines - adverse effects
Morpholines - therapeutic use
Pain Medicine
Propanolamines - administration & dosage
Safety
Tachycardia, Supraventricular - drug therapy
Tachycardia, Supraventricular - physiopathology
Treatment Outcome
Urea - administration & dosage
Urea - adverse effects
Urea - analogs & derivatives
Urea - therapeutic use
Young Adult
title Landiolol in the treatment of the intraoperative supraventricular tachycardia: a multicenter, randomized, double-blind, placebo-controlled study
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