COVIDAR - Arrhythmias in COVID-19

Atrial Fibrillation Clinical Trial

— COVIDAR  

Official title:

COVIDAR - International Registry on Arrhythmias in COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04437901
• Other study ID #: HCB/2020/0333
• Status: Not yet recruiting
• Start date: June 2020
• Est. completion date: December 2021

Study information

• Verified date: June 2020
• Source: Hospital Clinic of Barcelona
• Contact: Elena Arbelo, MD, PhD
• Phone: +34 93 227 5551
• Email: EARBELO[@]clinic.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrioventricular Block
• Bradyarrhythmia
• Bradycardia
• COVID
• Qt Interval, Variation in
• Torsades de Pointe Caused by Drug
• Torsades de Pointes
• Ventricular Arrythmia

Locations

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

Sponsors (7)

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

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

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