Sacubitril/valsartan fails to improve cardiovascular biomarkers for people with recent COVID-19 infections: PARACOR-19 trial
USA: In a significant development in the fight against COVID-19, the PARACOR-19 randomized clinical trial (RCT) results shed light on the potential cardiovascular benefits of Sacubitril/Valsartan among patients recovering from recent COVID-19 infection. This groundbreaking study, conducted by a team of medical experts from prestigious institutions, offers new insights into managing cardiovascular complications in individuals post-COVID-19.
The pilot RCT of patients who recovered from acute COVID-19 showed that sacubitril/valsartan did not improve cardiovascular biomarkers. Exploratory analyses suggested the potential benefits of sacubitril/valsartan on cardiac wall stress and collagen turnover as measured by NT-proBNP and C-terminal telopeptide of collagen type I (CITP). Sacubitril/valsartan was well tolerated.
The findings of the PARACOR-19, a single-center, double-blind RCT, were published online in the European Journal of Heart Failure on May 11, 2024.
The PARACOR-19 was designed by Stephen J. Greene, Duke Clinical Research Institute, Durham, NC, USA, and colleagues to examine the effects of sacubitril/valsartan on markers of cardiac injury, function, inflammation, and structure among patients who have recovered from acute coronavirus disease 2019 (COVID-19) infection.
The trial included patients with cardiovascular risk factors and a history of COVID-19 infection 4–16 weeks before enrolment. They were randomized to sacubitril/valsartan (titrated to the maximum dose of 97/103 mg twice daily) versus a matching placebo.
Co-primary endpoints were a change in high-sensitivity cardiac troponin T (hs-cTnT) and soluble ST2 (sST2) from baseline to 12 weeks. Exploratory endpoints included change in additional circulating biomarkers from baseline to 12 weeks.
Overall, 42 patients were randomized between 2021 and 2023 (n = 20 sacubitril/valsartan, n = 22 placebo). The median time from COVID-19 diagnosis to enrolment was 67 days. The median age was 67 years, 48% were females.
The study revealed the following findings:
- Compared with placebo, sacubitril/valsartan did not significantly impact the co-primary endpoints of change from baseline in hs-TnT and sST2.
- In exploratory analyses, sacubitril/valsartan led to a 46% greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) and a 51% greater reduction in C-terminal telopeptide of collagen type I.
- Permanent drug discontinuation occurred in four patients in the sacubitril/valsartan group and three patients in the placebo group.
- There were no deaths, and one patient was hospitalized in each group.
In the pilot, RCT of patients who recovered from acute COVID-19, sacubitril/valsartan failed to lower hs-cTnT or sST2 compared with a placebo. Exploratory analyses indicate its potential benefits on cardiac wall stress and collagen turnover as measured by CITP and NT-proBNP. Sacubitril/valsartan was well tolerated.
Reference:
Greene, S. J., Chambers, R., Lerman, J. B., Harrington, J., Wendell, D. C., Kim, H. W., Green, C. L., Butler, J., & Felker, G. M. Sacubitril/valsartan and cardiovascular biomarkers among patients with recent COVID-19 infection: The PARACOR-19 randomized clinical trial. European Journal of Heart Failure. https://doi.org/10.1002/ejhf.3199
