Status:
COMPLETED
Stopping ACE-inhibitors in COVID-19
Lead Sponsor:
Medical University Innsbruck
Collaborating Sponsors:
Ludwig-Maximilians - University of Munich
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Conditions:
SARS-CoV-2
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
ACEI-COVID-19 is a multicenter, randomized trial testing the hypothesis that stopping/replacing chronic treatment with ACE-inhibitors (ACEI) or angiotensin receptor blockers (ARB) improves outcomes in...
Detailed Description
The COVID-19 pandemic currently poses unprecedented challenges to the health systems of all countries. Experimental studies show that the SARS-CoV2 virus enters human cells via the angiotensin convert...
Eligibility Criteria
Inclusion
- Female and male patients competent to make a decision
- Proven and symptomatic SARS-CoV2 infection ≤ 5 days
- Patient age ≥ 18 years
- Provided written informed consent
- Chronic (≥ 1 month) ACEI/ARB therapy for treatment of arterial hypertension, diabetes mellitus, heart failure or coronary artery disease
- Stable hemodynamic conditions allowing to stop or continue treatment with ACEI/ARB (systolic blood pressure ≤180mmHg)
Exclusion
- Women capable of bearing children as well as pregnant and breastfeeding women
- Participant in another interventional trail
- At screening visit, no oral medication intake possible
- Advanced heart failure NYHA Stage III-IV
- Left ventricular ejection fraction \<30% or NTproBNP ≥600pg/mL in case of clinical signs of heart failure
- Acute coronary syndrome ≤ 3 months
- Severe arterial hypertension (concomitant use of more than 4 different antihypertensive drug classes)
- Acute respiratory distress syndrome with need for mechanical ventilation
- Patients who at not capable of home blood pressure monitoring
- Patients who cannot be switched to an alternative medication
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2021
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04353596
Start Date
April 20 2020
End Date
February 24 2021
Last Update
September 13 2022
Active Locations (31)
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1
Medical University Innsbruck, University Hospital of Internal Medicine III
Innsbruck, Tyrol, Austria, 6020
2
Medical University of Graz
Graz, Austria
3
Landeskrankenhaus Hall
Hall in Tirol, Austria
4
Medical University Innsbruck, Intensive Care and Emergency Medicine Department
Innsbruck, Austria