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IRCT20151113025025N3 IRCT 2020-03-29 Tehran University of Medical Sciences Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with coronavirus disease-2019 (COVID-19) referring to Sina and Imam-Khomeini Hospitals in 2020 corona virus disease-2019 (COVID-19) Clinical Trial of renin-angiotensin-aldosterone system inhibitors with halting their administration and the effect on clinical outcomes of patients with coronavirus disease-2019 (COVID-19) referring to Sina and Imam-Khomeini Hospitals in 2020 2020-04-05 anticipated 60 Complete https://irct.ir/trial/46531 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients consuming renin-angiotensin-aldosterone system inhibitors are recruited in the study using computerized-sequence random codes in 2 groups, Blinding description: The physicians recruiting patients' data and the statistician are blinded whether the antihypertensive medication will be continued or withheld. A pharmacotherapist will consult with a cardiologist for the patient group whose antihypertensive medication should be changed. At the time of discharge, this medication will be prescribed by the cardiologist who is not blinded and not responsible for data gathering. 4 COVID-19. Intervention 1: Intervention group: Discontinuation of agents inhibiting renin-angiotensin-aldosterone system substituting by calcium channel blocker with or without beta-blocker. Intervention 2: Control group: Continuation of renin-angiotensin-aldosterone inhibiting agents. Yes - There is a plan to make this available What will be shared: Data will be shared if a journal wants to. When: At the time of publishing the article To whom: Journal editor or reviewers Conditions: In case of a request from journal reviewers or editors Where to obtain: They can email me. How to obtain: They can email me. Comments:
public Maryam Bahreini
Sina Hospital, Imam-Khomeini Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1136546911 +98 21 6312 1413 bahreinimaryam@gmail.com Tehran University of Medical Sciences scientific Maryam Bahreini
Sina Hospital, Imam-Khomeini Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1136546911 +98 21 6312 1413 bahreinimaryam@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who have suggestive signs of COVID-19 in their chest computed tomography scan, reported by a radiologist Patients consuming angiotensin converting enzyme-inhibitors or angiotensin receptor blocker 18 years no limit Both Uncontrolled hypertension with systolic blood pressure more than 180 or diastolic more than 120 Past history of congested heart failure or arrhythmia with various severity Sensitivity to the newly-prescribed medications History of severe asthma History of known depression Consuming medications with interactions such as lithium, antiepileptic drugs, chemotherapy Pregnancy Patient unwillingness to enter the study Patients whose prognosis is influenced by another disease U07.1 corona virus disease 2019 Treatment - Drugs Treatment - Drugs Intervention group: Discontinuation of agents inhibiting renin-angiotensin-aldosterone system substituting by calcium channel blocker with or without beta-blocker Control group: Continuation of renin-angiotensin-aldosterone inhibiting agents Death. Timepoint: 3 months. Method of measurement: Number of deceased patients. ICU admission. Timepoint: 6 months. Method of measurement: Number of deceased patients. Tehran University of Medical Sciences Approved 1985-06-17 Vice Chancellor in Research Affairs-Tehran University of Medical Sciences Sina Hospital, Imam-Khomeini Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)