Status:
TERMINATED
ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Groupe Hospitalier Pitié-Salpêtrière
Conditions:
History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Since December 2019, a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19. Individ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old.
- Chronically treated with RAS blockers (ACE inhibitors or ARBs on the last prescription prior to admission with a treatment duration ≥ 1 month).
- Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample with any detection method.
- Patients hospitalized in a non-intensive care unit.
- Pregnancy test at inclusion visit for women of childbearing potential.
- Women of childbearing potential must agree to use adequate contraception according to recommendations related to contraception and pregnancy testing in clinical trials, by Clinical Trial Facilitation Group (CTFG).
Exclusion
- Shock requiring vasoactive agents.
- Acute respiratory distress syndrome requiring invasive mechanical ventilation.
- Circulatory assistance.
- History of malignant hypertension according to the definition of the 2018 ESC/ESH guidelines on hypertension.
- Uncontrolled blood pressure despite the use of five antihypertensive drugs.
- History of nephrotic syndrome.
- History of hospitalization for hemorrhagic stroke in the past 3 months.
- RAS blockers therapy previously stopped \> 48h.
- No affiliation to the French Health Care System "Sécurité Sociale".
- Inability to obtain informed consent.
Key Trial Info
Start Date :
April 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04329195
Start Date
April 9 2020
End Date
January 9 2021
Last Update
April 9 2021
Active Locations (1)
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1
Cardiologie, Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013