Key result
Planned observational study will evaluate long-term CV and renal impacts of SARS-CoV-2 in CKD.
Why the study?
Pre-existing cardiovascular disease and chronic kidney disease are linked to severe COVID-19 and worse prognosis, but the long-term impact on cardiovascular and renal outcomes remains to be defined.
Does SARS-CoV-2 infection increase long-term cardiovascular risk and endothelial dysfunction in patients with CKD, dialysis, or kidney transplants compared to matched controls?
Observational (n=250)
Yes
Does SARS-CoV-2 infection increase long-term cardiovascular risk and endothelial dysfunction in patients with CKD, dialysis, or kidney transplants compared to matched controls?
This study protocol outlines a multi-center observational trial to assess the long-term cardiovascular and renal impacts of COVID-19 in patients with advanced CKD and kidney transplants.
Long-term CV/renal risks after SARS-CoV-2 in CKD remain undefined; this planned cohort leaves the question open.
BACKGROUND: The coronavirus disease (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) produced a pandemic since March 2020 by affecting more than 243 million people with more than 5 million deaths globally. SARS-CoV-2 infection is produced by binding to angiotensin-converting enzyme, which among other sites is highly expressed in the endothelial cells of the blood vessels, pericytes and the heart, as well as in renal podocytes and proximal tubular epithelial cells. SARS-CoV-2 and cardiovascular disease (CVD) are interconnected by risk factors association with an increased incidence of the disease and by determining de novo cardiac complications. At the same time, COVID-19 disease can lead to acute kidney injury directly, or due to sepsis, multi-organ failure and shock. Therefore, the pre-existence of both CVD and chronic kidney disease (CKD) is linked with a higher risk of severe disease and worse prognosis. METHODS: The main aim of this study is to assess the CV risk in a CKD (stage 3 to 5), dialysis and kidney transplanted population, following SARS-CoV-2 infection, with focus on the endothelial dysfunction as compared to a control group of matched patients. By using clinical evaluation, flow-mediated dilatation, carotid-femoral pulse wave velocity, intima-media thickness, echocardiographic parameters, lung ultrasound, bioimpedance spectroscopy and a series of novel biomarkers, the investigators will determine the long-term impact of this disease on CV and renal outcomes. DISCUSSION: This study will address the challenges and implications in long-term CV sequeale of COVID-19 and focus on a better understanding of the underlying mechanisms and possible therapeutic options. TRIAL REGISTRATION: Patient enrolment in the trial started in January 2021 and is expected to finish at the end of 2022. The study can be found on ClinicalTrials.gov database with NCT05125913 identifier. Registered on 18 November 2021 - Retrospectively registered.
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Țăpoi et al. (2022) conducted an observational in Chronic kidney disease, dialysis, and kidney transplant (n=250). SARS-CoV-2 infection vs. Matched patients without a history of SARS-CoV-2 infection was evaluated on All-cause mortality rate, a composite CV outcome (time to first non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure or CV death), and markers of CV risk and endothelial dysfunction. SARS-CoV-2 infection's long-term impact on cardiovascular and renal outcomes in patients with chronic kidney disease will be evaluated in this planned observational matched cohort study.
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