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SARS-CoV-2 疾病后慢性肾脏病和肾移植患者的长期心血管风险评估:多中心观察性匹配对照试验方案。

Long-term cardio-vascular risk assessment in chronic kidney disease and kidney transplanted patients following SARS-COV-2 disease: protocol for multi-center observational match controlled trial.

机构信息

Department of Internal Medicine, Nephrology and Geriatrics, Grigore T Popa University of Medicine and Pharmacy, Iasi, Romania.

Cardiovascular Diseases Institute Prof. Dr. George I.M. Georgescu, Iasi, Romania.

出版信息

BMC Nephrol. 2022 May 6;23(1):176. doi: 10.1186/s12882-022-02809-4.

DOI:10.1186/s12882-022-02809-4
PMID:35524223
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9077937/
Abstract

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.

摘要

背景

自 2020 年 3 月以来,由严重急性呼吸系统综合征冠状病毒 2(SARS-CoV-2)引起的冠状病毒病(COVID-19)通过影响全球超过 2.43 亿人并导致超过 500 万人死亡而引发了大流行。SARS-CoV-2 感染是通过与血管内皮细胞、周细胞和心脏中的血管紧张素转换酶结合而产生的,该酶在肾脏足细胞和近端肾小管上皮细胞中也高度表达。SARS-CoV-2 和心血管疾病(CVD)通过与疾病发病率增加相关的危险因素以及确定新的心脏并发症而相互关联。与此同时,COVID-19 疾病可直接导致急性肾损伤,或因败血症、多器官衰竭和休克而导致。因此,CVD 和慢性肾脏病(CKD)的预先存在与严重疾病和预后不良的风险增加有关。

方法

本研究的主要目的是评估 COVID-19 感染后 CKD(3 至 5 期)、透析和肾移植人群的 CV 风险,重点关注与对照组匹配患者相比的内皮功能障碍。通过临床评估、血流介导的扩张、颈动脉-股动脉脉搏波速度、内-中膜厚度、超声心动图参数、肺部超声、生物阻抗谱和一系列新型生物标志物,研究人员将确定该疾病对 CV 和肾脏结局的长期影响。

讨论

本研究将解决 COVID-19 长期 CV 后遗症的挑战和影响,并重点关注对潜在机制和可能治疗选择的更好理解。

试验注册

该试验的患者入组于 2021 年 1 月开始,预计于 2022 年底结束。该研究可在 ClinicalTrials.gov 数据库中以 NCT05125913 标识符找到。于 2021 年 11 月 18 日注册 - 回顾性注册。

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