Status:
UNKNOWN
Prevention of Acute Myocardial Injury by Trimetazidine in Patients Hospitalized for COVID-19
Lead Sponsor:
Ministry of Health, Brazil
Collaborating Sponsors:
InCor Heart Institute
Conditions:
Acute Respiratory Distress Syndrome
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Acute myocardial injury has been a finding of variable frequency among patients diagnosed with COVID-19. It is now recognized that cTnI levels are strongly associated with increased mortality. The mec...
Detailed Description
Acute myocardial injury, defined by increased levels of high-sensitivity cardiac troponin I (cTnI), has been a finding of variable frequency among patients diagnosed with COVID-19. This myocardial imp...
Eligibility Criteria
Inclusion
- A.
- Clinical diagnosis of moderate to severe acute respiratory syndrome due to SARS-CoV2 defined as:
- 1. Tachypnea: \> 24 breaths per minute 1.2. Hypoxemia: arterial oxygen saturation \<94% in room air by pulse oximetry 1.3. Presumptive (or confirmed) diagnosis of SARS-Cov2 infection by at least one of the following criteria:
- Polymerase chain reaction assay (+) for SARS-CoV2
- Serology (+) for SARS-CoV2
- SARS-CoV2 antigen diagnostic tests (+)
- Chest CT with findings suggestive of the diagnosis of COVID-19 in the presence of medical history or clinical signs compatible with the diagnosis of COVID-19
- Signature of the Informed Consent Form
- B.
Exclusion
- Chronic renal dysfunction stage 4 (GFR \<30mL / min / 1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- Patient on renal replacement therapy by dialysis
- Pregnant and lactating women
- Previous use of trimetazidine less than two weeks before hospital admission
- Any clinical condition at the investigator´s discretion likely to be associated with elevation of baseline hs-troponin \>99th percentile
Key Trial Info
Start Date :
December 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04760821
Start Date
December 10 2020
End Date
April 30 2021
Last Update
February 21 2021
Active Locations (1)
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1
Heart Institute (InCor-HCFMUSP)
São Paulo, São Paulo, Brazil, 05403-000