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

COVID-19 Clinical Trial

Official title:

Opportunistic Screening for Asymptomatic Left Ventricular Dysfunction in COVID-19 Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04355884
• Other study ID #: COVID_LVD_SCREEN
• Status: Not yet recruiting
• Start date: April 20, 2020
• Est. completion date: May 1, 2020

Study information

• Verified date: April 2020
• Source: The University of Hong Kong
• Contact: Chung Wah SIU, MD
• Phone: 852-2255-4694
• Email: cwdsiu[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong, Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New-onset cardiac arrhythmia	Atrial fibrillation, conduction block	At the time of screening
Primary	Elevation of NT-proBNP	Elevated NT-proBNP level above the age-specific diagnostic threshold of heart failure	At the time of screening
Primary	Left ventricular dysfunction	Left ventricular systolic function	At the time of screening