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Opportunistic Screening for Asymptomatic Left Ventricular Dysfunction in Coronavirus Disease 2019 (COVID19) Survivors

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ClinicalTrials.gov Identifier: NCT04355884
Recruitment Status : Not yet recruiting
First Posted : April 21, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Brief Summary:

Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. Substantial proportion of patients with COVID-19 have biochemical evidence of myocardial injuries during the acute phase. Possible mechanisms including acute coronary events, cytokine storm, and COVID-19 related myocarditis, have been postulated for the cardiac involvement in COVID-19. It is uncertain whether COVID-19 survivors are at risk cardiac dysfunction including cardiac arrhythmia and heart failure.

The prospective screening study aims to evaluate the possible latent effects from COVID-19 in COVID-19 survivors. COVID-19 survivors 4-6 weeks after hospital discharge will be recruited from the Infectious Disease clinic, Queen Mary Hospital with standard 12-lead electrocardiogram, serum troponin, NT-proBNP, and standard transthoracic echocardiogram.

The outcome measures include (1) new onset cardiac arrhythmia, (2) N Terminal (NT)-proBNP elevation above the diagnostic range of heart failure, and (3) newly detected left ventricular dysfunction.


Condition or disease Intervention/treatment
COVID-19 Diagnostic Test: Standard 12-lead ECG, NT-proBNP, echocardiography

Detailed Description:

Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. As of April 2020, over 2 million populations were infected and more than 150,000 deaths globally. In the initial report from Wuhan, China, up to 27.8% COVID19 patients had an elevated troponin level indicating myocardial damage during the index hospitalization for COVID. This is nearly 10-folded higher than that of other common viral illnesses such as influenza (2.9%). Possible mechanisms including acute coronary events, cytokine storm, and COVID-19 related myocarditis, have been postulated for the cardiac involvement in COVID-19. Nonetheless, it is unknown whether COVID-19 survivors are at risk cardiac dysfunction including cardiac arrhythmia and heart failure.

The prospective screening study aims to evaluate the possible latent effects from COVID-19 in COVID-19 survivors. COVID-19 survivors 4-6 weeks after hospital discharge will be recruited from the Infectious Disease clinic, Queen Mary Hospital. Standard 12-lead electrocardiogram, serum troponin, NT-proBNP, and standard transthoracic echocardiogram will be performed for COVID-19 survivors.

The outcome measures include (1) new onset cardiac arrhythmia, (2) NT-proBNP elevation above the diagnostic range of heart failure, and (3) newly detected left ventricular dysfunction.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Opportunistic Screening for Asymptomatic Left Ventricular Dysfunction in COVID-19 Survivors
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Intervention Details:
  • Diagnostic Test: Standard 12-lead ECG, NT-proBNP, echocardiography
    Cardiac assessment


Primary Outcome Measures :
  1. New-onset cardiac arrhythmia [ Time Frame: At the time of screening ]
    Atrial fibrillation, conduction block

  2. Elevation of NT-proBNP [ Time Frame: At the time of screening ]
    Elevated NT-proBNP level above the age-specific diagnostic threshold of heart failure

  3. Left ventricular dysfunction [ Time Frame: At the time of screening ]
    Left ventricular systolic function



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Survivors of PCR-confirmed COVID-19 2-6 weeks after hospital discharge with 2 consecutive negative PCR for SARS-CoV-2 and without pre-existing heart failure, left ventricular dysfunction, and/or atrial fibrillation
Criteria

Inclusion Criteria:

  • Survivors of PCR-confirmed COVID-19
  • 2-6 weeks after hospital discharge with 2 consecutive negative polymerase chain reaction (PCR) for severe acute respiratory syndrome (SARS) coronavirus (CoV)-2.

Exclusion Criteria:

  • Pre-existing heart failure
  • Pre-existing left ventricular systolic dysfunction (left ventricular ejection fraction < 50%)
  • Pre-existing atrial fibrillation
  • Failure to provide informed consent

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): NCT04355884


Contacts
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Contact: Chung Wah SIU, MD 852-2255-4694 cwdsiu@hku.hk
Contact: Venus HO, BSc *52-22553597 vslho@hku.hk

Locations
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Hong Kong
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04355884    
Other Study ID Numbers: COVID_LVD_SCREEN
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 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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Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases