Atrial Fibrillation Clinical Trial
— COVIDAROfficial title:
COVIDAR - International Registry on Arrhythmias in COVID-19
BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia
occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand,
treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and
pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging
drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the
occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify
potential modifiable predisposing factors to reduce their incidence and to inform the best
arrhythmia management options in this patient population.
MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the
SARS-CoV2 infection.
STUDY DESIGN: patient registry (observational). Patients will not undergo any additional
investigations. Only data that is generated during routine clinical care will be collected.
STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed
COVID-19.
Status | Not yet recruiting |
Enrollment | 10000 |
Est. completion date | December 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients admitted with highly suspected/confirmed infection with SARS-CoV-2. Exclusion Criteria: - Formal opposition by the patient to data collection. |
Country | Name | City | State |
---|---|---|---|
Belgium | Antwerp University Hospital | Antwerpen | |
Italy | Istituto Auxologico Italiano, IRCCS | Milan | |
Netherlands | Amsterdam UMC | Amsterdam | AZ |
Spain | Hospital Clinic of Barcelona | Barcelona | |
United Kingdom | St. Georges University Hospitals | London |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), European Reference Network for Rare and Low Prevalence Complex Diseases of the Heart (ERN GUARDHEART), European Society of Cardiology, Istituto Auxologico Italiano, St George's University Hospitals NHS Foundation Trust, University Hospital, Antwerp |
Belgium, Italy, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arrhythmia | Any arrhythmic event occurring in COVID-19 patients during hospital admission: Monomorphic ventricular tachycardia Polymorphic ventricular tachycardia/Torsades de pointes (non-sustained) Ventricular fibrillation AV-block Severe bradycardia, symptomatic and/or requiring treatment New-onset atrial fibrillation Other |
From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months | |
Secondary | Electrocardiographic changes - Underlying rhythm | Categorical variable collecting the patient's underlying rhythm at baseline, on treatment and in case of arrhythmic adverse events): sinus rhythm, atrial fibrillation/flutter, other | From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months | |
Secondary | Electrocardiographic changes - Atrioventricular conduction | Collected as a categorical (normal, 1st-, 2nd- or 3rd degree AV block) and a continuous (PR duration in ms) at baseline, on treatment and in case of arrhythmic adverse events) | From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months | |
Secondary | Electrocardiographic changes - QRS duration | Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events) | From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months | |
Secondary | Electrocardiographic changes - presence of Brugada QRS pattern | Collected as a categorical variable (not present, type 1 or type 2) at baseline, on treatment and in case of arrhythmic adverse events) | From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months | |
Secondary | Electrocardiographic changes - QTc duration | Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events) | From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months | |
Secondary | Laboratory abnormalities - electrolyte misbalance | Kalium, magnesium and calcium collected as continuous variables at baseline, on treatment and in case of arrhythmic adverse events). Will be reported as a categorical variable (presence/absence) of electrolyte misbalance | From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months | |
Secondary | Laboratory abnormalities - cardiac biomarkers | Cardiac CK, troponin T and/or troponin I (where available) collected as a continuous variable at baseline, on treatment and in case of arrhythmic adverse events) | From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months | |
Secondary | Laboratory abnormalities - renal function | Creatinine clearance at baseline, on treatment and in case of arrhythmic adverse events) | From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months | |
Secondary | Laboratory abnormalities - liver function | Liver enzymes collected at at baseline, on treatment and in case of arrhythmic adverse events) | From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months |
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