Covid19CoViDExNCT04726150
Effect of CoVid-19 (CoronaVirusDisease-19) and Exercise on Myocardial Fibrosis and Ventricular Arrhythmias
An observational study of Covid19 and Athletes Heart, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Athletes Heart, Myocarditis Viral
- What is being tested?
- ILR implantation
- How many people
- 85 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2021to 31 Oct 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Athletes >= 18 years if age who suffered from COVID, who are at least one month post diagnosis of COVID-19 and who are willing to start exercising again
Who may be able to join
- Athletes (professional or recreational but aiming to compete at a national or international level), performing mixed-type or endurance sports as defined by Pelliccia et al. who:
- have recovered from a proven (either by PCR (Polymerase Chain Reaction), serology or chest Computed Tomography) COVID-19 infection
- are more than 1-month post onset of symptoms or the first positive PCR and
- are willing to start (or are) exercising again
Who cannot join
- known prior cardiac fibrosis
- known or newly diagnosed coronary artery disease
- allergy or contraindications for gadolinium contrast.
- unwillingness or impossibility to give informed consent
- Presence of edema on the CMR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of CoVid-19 and Exercise on Myocardial Fibrosis and Ventricular Arrhythmias (CovidEx)
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"
Read the detailed description
Baseline investigations will depend on the clinical presentation of the athlete. Three groups are identified:
- Asymptomatic/mildly symptomatic: anosmia, ageusia, headache, mild fatigue, fever ≤3d, myalgias ≤3d , mild upper respiratory tract illness, and mild gastrointestinal illness
- Moderate to severe symptoms: at least 2 of: persistent fever ≥4d, chills ≥4d, myalgias ≥4d, lethargy impairing activities of daily life (ADL) ≥4d, dyspnea during ADL ≥4d, and chest tightness ≥4d. Or cardiac symptoms: dyspnea, exercise intolerance, chest tightness, dizziness, (pre)syncope, and (new onset) palpitations.
- Hospitalized: all athletes admitted for COVID-19, whether or not on the intensive care unit.
- Group 1 will undergo a thorough history, clinical examination, ECG, laboratory tests for hs-Troponin T (TnT) and hsCRP, echocardiography at rest, 5-day-Holter and CMR. These examinations will take place at least 30 days after the first symptoms or positive test. Follow-up will be performed as pointed out with the grey crosses in the table. Depending on the results further investigation may be required (as in group 2 and 3). This part of the study is interventional in nature (not according to standard of care in those individuals).
- Groups 2 and 3 will undergo a more extensive evaluation: a thorough history, clinical examination, ECG, laboratory tests for hs-TnT and hsCRP, echocardiography at rest, CardioPulmonary Exercise Test (CPET), 5-day-Holter, late potentials and CMR.
If in any athlete the CMR shows signs of fibrosis or myocarditis, an exercise echocardiography will be performed additionally. Those subjects will be part of a more extensive follow-up schedule (both white and grey in the table) In the case of the presence of a non-ischemic pattern of Late Gadolinium Enhancement (LGE) or raised myocardial T2 and normal of only mildly contractile reserve, implantation of an Implantable Loop Recorder (ILR) will be performed as a part of the study. This then will be remotely followed-up through telemonitoring. Other athletes (and those who refuse an ILR will receive a 5d-Holter monitoring.
Amendment:
Athletes having undergone complete vaccination will be asked to provide the investigators with their training data prior to and following boostervaccination. Those athletes undergo investigations already included in the COVIDEX study, albeit in a condensed manner (Ergospirometry, Echocardiography and Blood Sample). These tests will take place at the day before the second vaccination and seven days after. Those athletes will also be asked to provide the investigators with their training data prior to and following vaccination.
- Conditions
- Covid19, Athletes Heart, Myocarditis Viral, Ventricular Arrythmia
- Being tested
- ILR implantation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILR implantationOther
If LGE is present on CMR, ILR implantation will be proposed
| Study group | Role | What they receive |
|---|---|---|
| Mildly of Asymptomatic COVID | Athletes with prior COVID-19 that had a mildly or asymptomatic course Receives: Other: ILR implantation | |
| Moderate to Severe Symptoms, Cardiac Symptoms | Athletes with prior COVID-19 that had a moderate to severely symptomatic course, or who experience(d) cardiac symptoms Receives: Other: ILR implantation | |
| Hospitalized for | Athletes that were hospitalized for COVID-19 Receives: Other: ILR implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of athletes with LGE on CMR
Measured: 6months - 3 years post COVID diagnosis
Arrhythmic Burden on ILR
Measured: 6months to 2 to3 years post implantation (depending on device longevity)
Arrhythmic Burden on 5d Holter
Measured: At inclusion
Arrhythmic Burden on 5d Holter
Measured: At 6 months
Arrhythmic Burden on 5d Holter
Measured: At 12 months
Arrhythmic Burden on 5d Holter
Measured: At 3 years
Secondary outcomes (2)
Occurrence of (pre)syncope or SCD
Measured: throughout the duration of the study, preamble is 3 years
Long-term evolution of cardiac function on echo/CMR: ejection fraction
Measured: reevaluation at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2021
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726150
- Sponsor's protocol ID
- 1499
- Acronym
- CoViDEx
- Status last verified
- Oct 2022
- First submitted
- 13 Jan 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CoVid-19 and Exercise on Myocardial Fibrosis and Ventricular Arrhythmias (CovidEx)
- ClinicalTrials.gov ID
- NCT04726150
- Acronym / sponsor ID
- CoViDEx / 1499
- Conditions
- Covid19, Athletes Heart, Myocarditis Viral, Ventricular Arrythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
Detailed description
Baseline investigations will depend on the clinical presentation of the athlete. Three groups are identified:
- Asymptomatic/mildly symptomatic: anosmia, ageusia, headache, mild fatigue, fever ≤3d, myalgias ≤3d , mild upper respiratory tract illness, and mild gastrointestinal illness
- Moderate to severe symptoms: at least 2 of: persistent fever ≥4d, chills ≥4d, myalgias ≥4d, lethargy impairing activities of daily life (ADL) ≥4d, dyspnea during ADL ≥4d, and chest tightness ≥4d. Or cardiac symptoms: dyspnea, exercise intolerance, chest tightness, dizziness, (pre)syncope, and (new onset) palpitations.
- Hospitalized: all athletes admitted for COVID-19, whether or not on the intensive care unit.
- Group 1 will undergo a thorough history, clinical examination, ECG, laboratory tests for hs-Troponin T (TnT) and hsCRP, echocardiography at rest, 5-day-Holter and CMR. These examinations will take place at least 30 days after the first symptoms or positive test. Follow-up will be performed as pointed out with the grey crosses in the table. Depending on the results further investigation may be required (as in group 2 and 3). This part of the study is interventional in nature (not according to standard of care in those individuals).
- Groups 2 and 3 will undergo a more extensive evaluation: a thorough history, clinical examination, ECG, laboratory tests for hs-TnT and hsCRP, echocardiography at rest, CardioPulmonary Exercise Test (CPET), 5-day-Holter, late potentials and CMR.
If in any athlete the CMR shows signs of fibrosis or myocarditis, an exercise echocardiography will be performed additionally. Those subjects will be part of a more extensive follow-up schedule (both white and grey in the table) In the case of the presence of a non-ischemic pattern of Late Gadolinium Enhancement (LGE) or raised myocardial T2 and normal of only mildly contractile reserve, implantation of an Implantable Loop Recorder (ILR) will be performed as a part of the study. This then will be remotely followed-up through telemonitoring. Other athletes (and those who refuse an ILR will receive a 5d-Holter monitoring.
Amendment:
Athletes having undergone complete vaccination will be asked to provide the investigators with their training data prior to and following boostervaccination. Those athletes undergo investigations already included in the COVIDEX study, albeit in a condensed manner (Ergospirometry, Echocardiography and Blood Sample). These tests will take place at the day before the second vaccination and seven days after. Those athletes will also be asked to provide the investigators with their training data prior to and following vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mildly of Asymptomatic COVID | – | Other: ILR implantationAthletes with prior COVID-19 that had a mildly or asymptomatic course |
| Moderate to Severe Symptoms, Cardiac Symptoms | – | Other: ILR implantationAthletes with prior COVID-19 that had a moderate to severely symptomatic course, or who experience(d) cardiac symptoms |
| Hospitalized for | – | Other: ILR implantationAthletes that were hospitalized for COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Athletes >= 18 years if age who suffered from COVID, who are at least one month post diagnosis of COVID-19 and who are willing to start exercising again
Key inclusion criteria (4 listed)
- Athletes (professional or recreational but aiming to compete at a national or international level), performing mixed-type or endurance sports as defined by Pelliccia et al. who:
Key exclusion criteria (5 listed)
- known prior cardiac fibrosis
- known or newly diagnosed coronary artery disease
- allergy or contraindications for gadolinium contrast.
- unwillingness or impossibility to give informed consent
- Presence of edema on the CMR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ILR implantationIf LGE is present on CMR, ILR implantation will be proposed | Other | Hospitalized for, Mildly of Asymptomatic COVID, Moderate to Severe Symptoms, Cardiac Symptoms |
Primary outcome
Percentage of athletes with LGE on CMR
Time frame: 6months - 3 years post COVID diagnosis
Arrhythmic Burden on ILR
Time frame: 6months to 2 to3 years post implantation (depending on device longevity)
Arrhythmic Burden on 5d Holter
Time frame: At inclusion
Arrhythmic Burden on 5d Holter
Time frame: At 6 months
Arrhythmic Burden on 5d Holter
Time frame: At 12 months
Arrhythmic Burden on 5d Holter
Time frame: At 3 years
2 secondary outcomes
Occurrence of (pre)syncope or SCD
Time frame: throughout the duration of the study, preamble is 3 years
Long-term evolution of cardiac function on echo/CMR: ejection fraction
Time frame: reevaluation at 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Athletes Heart, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of athletes with LGE on CMR (time frame: 6months - 3 years post COVID diagnosis). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.