Sacubitril/valsartan and cardiovascular biomarkers among patients with recent COVID-19 infection: The PARACOR-19 randomized clinical trial.
Biomarkers
COVID‐19
Sacubitril/valsartan
Journal
European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595
Informations de publication
Date de publication:
11 May 2024
11 May 2024
Historique:
revised:
19
02
2024
received:
24
01
2024
accepted:
05
03
2024
medline:
11
5
2024
pubmed:
11
5
2024
entrez:
11
5
2024
Statut:
aheadofprint
Résumé
The PARACOR-19 randomized controlled trial (RCT) was designed to examine the effects of sacubitril/valsartan on markers of cardiac injury, inflammation, structure, and function among patients who have recovered from acute coronavirus disease 2019 (COVID-19) infection. PARACOR-19 was a single-centre, double-blind RCT of patients with cardiovascular risk factors and a history of COVID-19 infection 4-16 weeks prior to enrolment. Patients were randomized to sacubitril/valsartan (titrated to the maximum dose of 97/103 mg twice daily) versus matching placebo. Co-primary endpoints were change from baseline to 12 weeks in high-sensitivity cardiac troponin T (hs-cTnT) and soluble ST2 (sST2). Exploratory endpoints included change from baseline to 12 weeks in additional circulating biomarkers. Overall, 42 patients were randomized between August 2021 and March 2023 (n = 20 sacubitril/valsartan, n = 22 placebo). Median (25th-75 In this pilot RCT of patients who recovered from acute COVID-19, sacubitril/valsartan did not lower hs-cTnT or sST2 compared with placebo. Exploratory analyses suggested potential benefits of sacubitril/valsartan on cardiac wall stress and collagen turnover as measured by NT-proBNP and CITP. Sacubitril/valsartan was well tolerated. ClinicalTrials.gov NCT04883528.
Banques de données
ClinicalTrials.gov
['NCT04883528']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 European Society of Cardiology.
Références
Yancy CW, Fonarow GC. Coronavirus disease 2019 (COVID‐19) and the heart – Is heart failure the next chapter? JAMA Cardiol 2020;5:1216–1217. https://doi.org/10.1001/jamacardio.2020.3575
Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, et al. Outcomes of cardiovascular magnetic resonance imaging in patients recently recovered from coronavirus disease 2019 (COVID‐19). JAMA Cardiol 2020;5:1265–1273. https://doi.org/10.1001/jamacardio.2020.3557
Lindner D, Fitzek A, Brauninger H, Aleshcheva G, Edler C, Meissner K, et al. Association of cardiac infection with SARS‐CoV‐2 in confirmed COVID‐19 autopsy cases. JAMA Cardiol 2020;5:1281–1285. https://doi.org/10.1001/jamacardio.2020.3551
Salah HM, Fudim M, O'Neil ST, Manna A, Chute CG, Caughey MC. Post‐recovery COVID‐19 and incident heart failure in the National COVID Cohort Collaborative (N3C) study. Nat Commun 2022;13:4117. https://doi.org/10.1038/s41467‐022‐31834‐y
Acanfora D, Ciccone MM, Scicchitano P, Acanfora C, Casucci G. Neprilysin inhibitor‐angiotensin II receptor blocker combination (sacubitril/valsartan): Rationale for adoption in SARS‐CoV‐2 patients. Eur Heart J Cardiovasc Pharmacother 2020;6:135–136. https://doi.org/10.1093/ehjcvp/pvaa028
Cunningham JW, Claggett BL, O'Meara E, Prescott MF, Pfeffer MA, Shah SJ, et al. Effect of sacubitril/valsartan on biomarkers of extracellular matrix regulation in patients with HFpEF. J Am Coll Cardiol 2020;76:503–514. https://doi.org/10.1016/j.jacc.2020.05.072
Januzzi JL Jr, Prescott MF, Butler J, Felker GM, Maisel AS, McCague K, et al.; PROVE‐HF Investigators. Association of change in N‐terminal pro‐B‐type natriuretic peptide following initiation of sacubitril‐valsartan treatment with cardiac structure and function in patients with heart failure with reduced ejection fraction. JAMA 2019;322:1085–1095. https://doi.org/10.1001/jama.2019.12821
Vaduganathan M, Vardeny O, Michel T, McMurray JJV, Pfeffer MA, Solomon SD. Renin‐angiotensin‐aldosterone system inhibitors in patients with Covid‐19. N Engl J Med 2020;382:1653–1659. https://doi.org/10.1056/NEJMsr2005760
Morrow DA, Velazquez EJ, DeVore AD, Prescott MF, Duffy CI, Gurmu Y, et al. Cardiovascular biomarkers in patients with acute decompensated heart failure randomized to sacubitril‐valsartan or enalapril in the PIONEER‐HF trial. Eur Heart J 2019;40:3345–3352. https://doi.org/10.1093/eurheartj/ehz240
Cunningham JW, Vaduganathan M, Claggett BL, Zile MR, Anand IS, Packer M, et al. Effects of sacubitril/valsartan on N‐terminal pro‐B‐type natriuretic peptide in heart failure with preserved ejection fraction. JACC Heart Fail 2020;8:372–381. https://doi.org/10.1016/j.jchf.2020.03.002
McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, et al.; PARADIGM‐HF Investigators and Committees. Angiotensin‐neprilysin inhibition versus enalapril in heart failure. N Engl J Med 2014;371:993–1004. https://doi.org/10.1056/NEJMoa1409077
Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, et al.; PARAGON‐HF Investigators and Committees. Angiotensin‐neprilysin inhibition in heart failure with preserved ejection fraction. N Engl J Med 2019;381:1609–1620. https://doi.org/10.1056/NEJMoa1908655