COVIDAR - Arrhythmias in COVID-19
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
The COVIDAR Registry is an international longitudinal multicentre observational study worldwide which aims to assess the incidence, type and risk factors of arrhythmias in the context of SARS-CoV2 infection, also providing relevant information on events/management and major cardiovascular outcomes. During the course of the registry patients will be followed up according to the usual practice of the centres. Drug prescriptions and indications to perform diagnostic/therapeutic procedures will be completely left to the treating physicians.
The registry population will consist of patients presenting with a suspicion of SARS-CoV2 infection, who are hospitalised in a medical or surgical department of the participating hospitals. Patients will officially be enrolled in the COVIDAR Registry if the COVID-19 disease has formally been noted or confirmed in the patient's medical record.
The registry will include all patients and collect data at the following timepoints:
-
Admission: evaluation before SARS-CoV2 infection treatment initiation
-
On-treatment: evaluation 24-28h after treatment initiation
-
At any adverse event: evaluation if any adverse event occurs
-
At discharge: evaluation of clinical status at the end of the admission period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID-19 patients Patients admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2. |
Outcome Measures
Primary Outcome Measures
- Arrhythmia [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]
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
Secondary Outcome Measures
- Electrocardiographic changes - Underlying rhythm [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]
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
- Electrocardiographic changes - Atrioventricular conduction [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]
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)
- Electrocardiographic changes - QRS duration [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]
Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)
- Electrocardiographic changes - presence of Brugada QRS pattern [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]
Collected as a categorical variable (not present, type 1 or type 2) at baseline, on treatment and in case of arrhythmic adverse events)
- Electrocardiographic changes - QTc duration [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]
Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)
- Laboratory abnormalities - 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]
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
- Laboratory abnormalities - cardiac biomarkers [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]
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)
- Laboratory abnormalities - renal function [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]
Creatinine clearance at baseline, on treatment and in case of arrhythmic adverse events)
- Laboratory abnormalities - liver function [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]
Liver enzymes collected at at baseline, on treatment and in case of arrhythmic adverse events)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients admitted with highly suspected/confirmed infection with SARS-CoV-2.
Exclusion Criteria:
- Formal opposition by the patient to data collection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Antwerp University Hospital | Antwerpen | Belgium | ||
| 2 | Istituto Auxologico Italiano, IRCCS | Milan | Italy | 20149 | |
| 3 | Amsterdam UMC | Amsterdam | AZ | Netherlands | 1105 AZ |
| 4 | Hospital Clinic of Barcelona | Barcelona | Spain | 08036 | |
| 5 | St. Georges University Hospitals | London | United Kingdom | SW17 0QT |
Sponsors and Collaborators
- Hospital Clinic of Barcelona
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Istituto Auxologico Italiano
- St George's University Hospitals NHS Foundation Trust
- University Hospital, Antwerp
- European Reference Network for Rare and Low Prevalence Complex Diseases of the Heart (ERN GUARDHEART)
- European Society of Cardiology
Investigators
- Study Chair: Elena Arbelo, MD, PhD, MSc, Hospital Clinic of Barcelona
- Study Director: Arthur A Wilde, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study Director: Lia Crotti, MD, PhD, Istituto Auxologico Italiano, IRCCS
- Study Director: Elijah Behr, MD, PhD, St George's University Hospitals NHS Foundation Trust
- Study Director: Hein Heidbuchel, MD, PhD, University Hospital, Antwerp
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCB/2020/0333