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COVIDAR - Arrhythmias in COVID-19 (COVIDAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04437901
Recruitment Status : Not yet recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Group/Cohort
COVID-19 patients
Patients admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2.



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)



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437901


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

Locations
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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
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Study Chair: Elena Arbelo, MD, PhD, MSc Hospital Clinic of Barcelona
Study Director: 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
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Responsible Party: Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04437901    
Other Study ID Numbers: HCB/2020/0333
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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