COVIDAR - Arrhythmias in COVID-19 (COVIDAR)

• ClinicalTrials.gov Identifier: NCT04437901
• Recruitment Status: Unknown
• First Posted: June 18, 2020
• Last Update Posted: June 18, 2020
• Sponsor: Hospital Clinic of Barcelona
• Collaborators: 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
• Information provided by (Responsible Party): Hospital Clinic of Barcelona

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

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

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 10000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Target Follow-Up Duration: 12 Months
• Official Title: COVIDAR - International Registry on Arrhythmias in COVID-19
• Estimated Study Start Date: June 2020
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2021

Groups and Cohorts

Group/Cohort
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 :

1. Arrhythmia [ Time Frame: 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 :

1. Electrocardiographic changes - Underlying rhythm [ Time Frame: 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
2. Electrocardiographic changes - Atrioventricular conduction [ Time Frame: 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)
3. Electrocardiographic changes - QRS duration [ Time Frame: 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)
4. Electrocardiographic changes - presence of Brugada QRS pattern [ Time Frame: 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)
5. Electrocardiographic changes - QTc duration [ Time Frame: 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)
6. Laboratory abnormalities - electrolyte misbalance [ Time Frame: 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
7. Laboratory abnormalities - cardiac biomarkers [ Time Frame: 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)
8. Laboratory abnormalities - renal function [ Time Frame: 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)
9. Laboratory abnormalities - liver function [ Time Frame: 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

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts

Contact: Elena Arbelo, MD, PhD; +34 93 227 5551; EARBELO@clinic.cat

Locations

Belgium

Antwerp University Hospital

Antwerpen, Belgium

Contact: Hein Heidbuchel, MD, PhD hein.heidbuchel@uantwerpen.be

Principal Investigator: Hein Heidbuchel, MD, PhD

Italy

Istituto Auxologico Italiano, IRCCS

Milan, Italy, 20149

Contact: Lia Crotti, MD, PhD +39 02 6191 12374 l.crotti@auxologico.it

Principal Investigator: Lia Crotti, MD, PhD

Netherlands

Amsterdam UMC

Amsterdam, AZ, Netherlands, 1105 AZ

Contact: Arthur A Wilde, MD, PhD a.a.wilde@amsterdamumc.nl

Principal Investigator: Arthur A Wilde, MD, PhD

Sub-Investigator: Nynke Hoffman, MD, PhD

Spain

Hospital Clinic of Barcelona

Barcelona, Spain, 08036

Contact: Elena Arbelo, MD, PhD, MSc +34 93 227 5551 EARBELO@clinic.cat

Principal Investigator: Elena Arbelo, MD, PhD, MSc

Sub-Investigator: Marta Hernandez-Meneses, MD

Sub-Investigator: Alex Soriano, MD, PhD

United Kingdom

St. Georges University Hospitals

London, United Kingdom, SW17 0QT

Contact: Elijah Behr, MD, PhD +44 20 8725 4571 ebehr@sgul.ac.uk

Principal Investigator: Elijah Behr, MD, PhD

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

More Information

• Responsible Party: Hospital Clinic of Barcelona
• ClinicalTrials.gov Identifier: NCT04437901
• Other Study ID Numbers: HCB/2020/0333
• First Posted: June 18, 2020
• Last Update Posted: June 18, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Atrioventricular Block; Bradycardia; Torsades de Pointes; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Block; Cardiac Conduction System Disease; Tachycardia, Ventricular; Tachycardia