COVIDAR - Arrhythmias in COVID-19

NCT04437901 | Unknown

• 1 other identifier: HCB/2020/0333
• Study Type: observational
• Target: 10,000
• Locations: 5 countries
• Sites: 5

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.

Conditions

COVID; Arrhythmia; Torsades de Pointe Caused by Drug; Qt Interval, Variation in; Atrioventricular Block; Atrial Fibrillation; Bradyarrhythmia; Ventricular Arrythmia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

COVID-19 patients

Patients admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients admitted with highly suspected/confirmed infection with SARS-CoV-2.

You may not qualify if:

• Formal opposition by the patient to data collection.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Istituto Auxologico Italiano: collaborator
• St George's University Hospitals NHS Foundation Trust: collaborator
• University Hospital, Antwerp: collaborator
• European Reference Network for Rare and Low Prevalence Complex Diseases of the Heart (ERN GUARDHEART): collaborator
• European Society of Cardiology: collaborator

Study Sites (5)

Antwerp University Hospital

Antwerp, Belgium

Location

Istituto Auxologico Italiano, IRCCS

Milan, 20149, Italy

Location

Amsterdam UMC

Amsterdam, AZ, 1105 AZ, Netherlands

Location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

St. Georges University Hospitals

London, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrioventricular Block; Atrial Fibrillation; Bradycardia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease

Study Officials

• Elena Arbelo, MD, PhD, MSc

  Hospital Clinic of Barcelona

  STUDY CHAIR

• Arthur A Wilde, MD, PhD

  Amsterdam UMC

  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 DIRECTOR

Central Study Contacts

Elena Arbelo, MD, PhD

CONTACT

+34 93 227 5551; EARBELO@clinic.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 18, 2020
• Study Start: June 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

GB (1); NL (1); IT (1); BE (1); ES (1)