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NCT04726150: CoViDEx

Effect of CoVid-19 (CoronaVirusDisease-19) and Exercise on Myocardial Fibrosis and Ventricular Arrhythmias

Completed Last updated 1 December 2023
What this trial tests

trial testing ILR implantation in Covid19 in 85 participants. Completed in 31 October 2022.

Timeline
1 April 2021
Primary endpoint
31 December 2021
31 October 2022

Quick facts

Lead sponsorUniversity Hospital, Antwerp
StatusCompleted
Study typeOBSERVATIONAL
Enrollment85
Start date1 April 2021
Primary completion31 December 2021
Estimated completion31 October 2022
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Antwerp

Who can join

18 and older, any sex, with Covid19 or Athletes Heart. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

COVID-19 can cause myocarditis, which can cause myocardial fibrosis. This has been shown to increase mortality and morbidity among athletes. Several efforts have been made to guide sports participation after COVID-19, but not much scientific evidence is present to back-up those guidelines. The current initiative aims gain a heightened insight in this matter.To identify the presence of fibrosis athletes who recovered from COVID-19 will undergo CMR (Cardiac MRI). All athletes will also undergo echocardiography, 5-day Holtermonitoring among others. This will allow to determine whether differences between those with and those without fibrosis are present. If fibrosis is present, athletes will be offered an implantation of a very small monitoring device that will be able to detect arrhythmias with a much higher sensitivity. Also an exercise echocardiography will be performed, to determine the safety of continuation of athletic efforts. Amendment: Recently myocarditis and pericarditis have also been observed after the administration of mRNA-vaccines, specifically after the second dose. The effect of vaccination on exercise capacity is less clear. To investigate this we propose to amend the inclusion criteria for COVIDEX with "athletes undergoing or having undergone COVID vaccination"

Publications & conference data

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

  1. The Pathogenesis and Long-Term Consequences of COVID-19 Cardiac Injury.
    Siripanthong B, Asatryan B, Hanff TC, Chatha SR, et al · · 2022 · cited 73× · PMID 35165665 · DOI 10.1016/j.jacbts.2021.10.011
  2. Effect of BNT162b2 mRNA booster vaccination on VO<sub>2</sub> <sub>max</sub> in recreational athletes: A prospective cohort study.
    Miljoen H, Bekhuis Y, Roeykens J, Taha K, et al · · 2022 · cited 3× · PMID 36425900 · DOI 10.1002/hsr2.929
  3. Low rates of myocardial fibrosis and ventricular arrhythmias in recreational athletes after SARS-CoV-2 infection.
    Miljoen H, Favere K, Van De Heyning C, Corteville B, et al · · 2024 · PMID 38628312 · DOI 10.3389/fcvm.2024.1372028

Verify or expand the search:

Other recruiting trials for Covid19

Currently open trials in the same condition.

Other University Hospital, Antwerp trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04726150.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing