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Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial.
American Heart Journal ( IF 4.8 ) Pub Date : 2020-05-13 , DOI: 10.1016/j.ahj.2020.05.002
Renato D Lopes 1 , Ariane Vieira Scarlatelli Macedo 2 , Pedro Gabriel Melo de Barros E Silva 3 , Renata Junqueira Moll-Bernardes 4 , Andre Feldman 5 , Guilherme D'Andréa Saba Arruda 5 , Andrea Silvestre de Souza 6 , Denilson Campos de Albuquerque 7 , Lilian Mazza 3 , Mayara Fraga Santos 4 , Natalia Zerbinatti Salvador 4 , C Michael Gibson 8 , Christopher B Granger 9 , John H Alexander 9 , Olga Ferreira de Souza 5 ,
Affiliation  

Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN: BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 34 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels. SUMMARY: BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.

中文翻译:

连续与悬浮血管紧张素转换酶抑制剂和血管紧张素受体阻滞剂:对重症急性呼吸综合征冠状病毒2(SARS-CoV-2)住院患者不良结局的影响-BRACE CORONA试验。

由于使用血管紧张素转换酶抑制剂(ACEI)和血管紧张素受体阻滞剂(ARB)的患者上调,血管紧张素转换酶2(ACE2)的表达可能会增加。由于肾素-血管紧张素系统阻滞剂会增加ACE2(一种促进冠状病毒进入细胞的蛋白质)的水平,因此人们担心这些药物可能会增加产生严重和致命形式的COVID-19的风险。终止ACEI和ARB对COVID-19患者的影响尚不确定。设计:BRACE CORONA是一项实用,多中心,随机,IV期临床试验,旨在在巴西34个地点招募约500名参与者。将从正在进行的COVID-19疑似和确诊病例国家注册中心中识别出参与者。符合条件的使用肾素-血管紧张素系统阻滞剂(ACEI / ARB)且确诊为COVID-19的患者将被随机分配为继续接受ACEI / ARB治疗而非暂时停药30天的策略。主要结局是存活的中位数天数,并在30天后离开医院。次要结局包括COVID-19疾病的进展,全因死亡率,心血管原因死亡,心肌梗塞,中风,短暂性脑缺血发作,新发或恶化的心力衰竭,心肌炎,心包炎,心律不齐,血栓栓塞事件,高血压危象,呼吸衰竭,血液动力学失代偿,败血症,肾衰竭和肌钙蛋白,B型利钠肽(BNP),N端proBNP和D-二聚体水平。概要:
更新日期:2020-05-13
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