NCT05125913: CARDIO SCARS

Long Term Cardio-Vascular Risk Assessment in CKD and Kidney Transplanted Patients Following SARS-COV-2

Status unknown Last updated 21 January 2022

What this trial tests

trial testing FMD in CKD in 250 participants. Status unknown.

Timeline

4 January 2021

Primary endpoint
31 December 2023

31 March 2024

Quick facts

Lead sponsor	Grigore T. Popa University of Medicine and Pharmacy
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	250
Start date	4 January 2021
Primary completion	31 December 2023
Estimated completion	31 March 2024
Sites	1 location across Romania

Drugs / interventions tested

• FMD
• Arterial stiffness
• Assessment of IMT
• Echocardiography
• LUS
• BIS analysis
• Biomarkers determination

Conditions studied

• CKD — all drugs for CKD →
• Dialysis — all drugs for Dialysis →
• Kidney Transplant — all drugs for Kidney Transplant →
• COVID-19 — all drugs for COVID-19 →

Sponsor

Grigore T. Popa University of Medicine and Pharmacy

Who can join

18 and older, any sex, with CKD or Dialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The occurrence of novel coronavirus disease 2019 (COVID-19), caused by the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), has offered an unmatched global challenge for the healthcare research community. SARS-CoV-2 infection is produced by binding to angiotensin-converting enzyme (ACE2), 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. Autopsy studies detected the presence of SARS-CoV-2 in both myocardium and renal tissue, suggesting that COVID-19 profoundly influences the cardiovascular (CV) system and the kidneys and this may lead to long-termed cardio-pulmonary-renal consequences. Data emerging from the general population suggests that COVID-19 is essentially an endothelial disease, with possible deleterious long-term effects that are currently incompletely understood. Therefore, the investigators aim to assess the CV risk in a chronic kidney disease (CKD) including dialysis patients and kidney transplanted (KTx) population, following SARS-CoV-2 infection, by determining the long-term impact of this disease on CV and renal outcomes in the aforementioned population as compared to a control group of matched patients.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Post-acute COVID-19 syndrome and kidney diseases: what do we know?
   Copur S, Berkkan M, Basile C, Tuttle K, et al · · 2022 · cited 39× · PMID 35294747 · DOI 10.1007/s40620-022-01296-y
2. 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.
   Tapoi L, Apetrii M, Dodi G, Nistor I, et al · · 2022 · cited 2× · PMID 35524223 · DOI 10.1186/s12882-022-02809-4
3. The Impact of Prior COVID-19 on Long-Term Mortality and Echocardiographic Predictors in Chronic Kidney Disease Patients.
   Vasiliu L, Dodi G, Onofriescu M, Diaconu A, et al · · 2025 · cited 1× · PMID 40150021 · DOI 10.3390/diagnostics15060678
4. Long-Term Evolution of Post-COVID-19 Echocardiographic Parameters in Patients with Chronic Kidney Disease: A Prospective Comparative Observational Study.
   Vasiliu L, Diaconu A, Onofriescu M, Dodi G, et al · · 2025 · cited 1× · PMID 40142631 · DOI 10.3390/jcm14061823
5. The impact of COVID-19 on right ventricular function in chronic kidney disease patients
   · 2022
6. 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
   Tapoi L, Apetrii M, Dodi G, Nistor I, et al · · 2022 · DOI 10.21203/rs.3.rs-1236020/v1