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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.
Am Heart J. 2020 Aug; 226:49-59.AH

Abstract

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.

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Authors+Show Affiliations

Lopes RD
D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Brazilian Clinical Research Institute, São Paulo, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil. Electronic address: renato.lopes@dm.duke.edu.
Macedo AVS
D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil; Santa Casa de São Paulo, São Paulo, Brazil.
de Barros E Silva PGM
Brazilian Clinical Research Institute, São Paulo, Brazil.
Moll-Bernardes RJ
D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.
Feldman A
D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.
D'Andréa Saba Arruda G
D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.
de Souza AS
D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil; Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.
de Albuquerque DC
D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.
Mazza L
Brazilian Clinical Research Institute, São Paulo, Brazil.
Santos MF
D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.
Salvador NZ
D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.
Gibson CM
Harvard Medical School, Boston, MA, USA.
Granger CB
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
Alexander JH
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
de Souza OF
D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.
BRACE CORONA investigators
No affiliation info available

MeSH

Angiotensin Receptor AntagonistsAngiotensin-Converting Enzyme 2Angiotensin-Converting Enzyme InhibitorsBetacoronavirusBrazilCOVID-19Clinical Trials, Phase IV as TopicCoronavirus InfectionsHumansInpatientsMulticenter Studies as TopicPandemicsPeptidyl-Dipeptidase APneumonia, ViralPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicRenin-Angiotensin SystemSARS-CoV-2Virus IntegrationWithholding Treatment

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

32502882

Citation

Lopes, Renato D., et al. "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, vol. 226, 2020, pp. 49-59.
Lopes RD, Macedo AVS, de Barros E Silva PGM, et al. 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. Am Heart J. 2020;226:49-59.
Lopes, R. D., Macedo, A. V. S., de Barros E Silva, P. G. M., Moll-Bernardes, R. J., Feldman, A., D'Andréa Saba Arruda, G., de Souza, A. S., de Albuquerque, D. C., Mazza, L., Santos, M. F., Salvador, N. Z., Gibson, C. M., Granger, C. B., Alexander, J. H., & de Souza, O. F. (2020). 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, 226, 49-59. https://doi.org/10.1016/j.ahj.2020.05.002
Lopes RD, et al. 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. Am Heart J. 2020;226:49-59. PubMed PMID: 32502882.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Lopes,Renato D, AU - Macedo,Ariane Vieira Scarlatelli, AU - de Barros E Silva,Pedro Gabriel Melo, AU - Moll-Bernardes,Renata Junqueira, AU - Feldman,Andre, AU - D'Andréa Saba Arruda,Guilherme, AU - de Souza,Andrea Silvestre, AU - de Albuquerque,Denilson Campos, AU - Mazza,Lilian, AU - Santos,Mayara Fraga, AU - Salvador,Natalia Zerbinatti, AU - Gibson,C Michael, AU - Granger,Christopher B, AU - Alexander,John H, AU - de Souza,Olga Ferreira, AU - ,, Y1 - 2020/05/13/ PY - 2020/4/24/received PY - 2020/5/4/accepted PY - 2020/6/6/pubmed PY - 2020/8/28/medline PY - 2020/6/6/entrez SP - 49 EP - 59 JF - American heart journal JO - Am Heart J VL - 226 N2 - 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. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/32502882/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_ DB - PRIME DP - Unbound Medicine ER -