Effects of Discontinuing Renin-angiotensin System Inhibitors in Patients With and Without COVID-19 (RASCOVID-19)
Covid-19
About this trial
This is an interventional treatment trial for Covid-19 focused on measuring COVID-19, RAS, Renin-angiotensin system, Angiotensin II receptor blocker, Angiotensin converting enzyme inhibitor, ARB, ACEi
Eligibility Criteria
Group A and B
Inclusion Criteria:
- Verified COVID-19
- Hospital admitted
- Daily administration of RAS-inhibiting therapy
- Age 18 years and above
- Informed consent
Exclusion Criteria:
- Diagnosed with systolic heart failure (heart failure with reduced ejection fraction)
- Severe kidney disease; defined by estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2
- Severe hypertension; defined by systolic pressure >175 mm Hg and/or diastolic pressure >105 mm Hg
- Hypotension; defined by systolic pressure <100 mm Hg and/or diastolic pressure <60 mm Hg
- Non-compliance of RAS-inhibiting therapy; defined as an estimated adherence <80% assessed by a questionnaire in combination with checking the Danish electronic medication system "FMK" (obligatory for clinicians in Denmark to ensure the Danish electronic medication system "FMK" is correct and up-to-date) for redeemed prescriptions in the last six months; in borderline cases, the participant is assumed compatible
- Pregnancy or breastfeeding
Contra indications for receiving ACE inhibitors or ARBs:
- Severe liver disease
- Hypersensitivity or allergic reactions to the therapy
- Angioneurotic edema during previous treatments
- Family history of or previous idiopathic angioneurotic edema
- Treatment with sacubitril/valsartan or aliskiren
Group C and D:
Inclusion Criteria:
- Daily administration of RAS-inhibiting therapy
- Age 18 years and above
- Informed consent
Exclusion Criteria:
- Diagnosed with systolic heart failure (heart failure with reduced ejection fraction)
- Severe kidney disease; defined by estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2
- Severe hypertension; defined by systolic pressure >175 mm Hg and/or diastolic pressure >105 mm Hg
- Hypotension; defined by systolic pressure <100 mm Hg and/or diastolic pressure <60 mm Hg
- Non-compliance of RAS-inhibiting therapy; defined as an estimated adherence <80% assessed by a questionnaire in combination with checking the Danish electronic medication system "FMK" (obligatory for clinicians in Denmark to ensure the Danish electronic medication system "FMK" is correct and up-to-date) for redeemed prescriptions in the last six months; in borderline cases, the participant is assumed compatible
- Pregnancy or breastfeeding
Contra indications for receiving ACE inhibitors or ARBs:
- Severe liver disease
- Hypersensitivity or allergic reactions to the therapy
- Angioneurotic edema during previous treatments
- Family history of or previous idiopathic angioneurotic edema
- Treatment with sacubitril/valsartan or aliskiren
Sites / Locations
- Department of Medicine, Gentofte Hospital, University of Copenhagen
- Department of Medicine, Herlev Hospital, University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
A: COVID+ Continuation
B: Covid+ Discontinuation
C: COVID% Continuation
D: COVID% DIscontinuation
The enrolled patients will continue their prescribed ACEi/ARB in the same dose. The clinicians will be encouraged to continue the medication throughout the hospital admission but it will be permissable for the clinician to stop treatment if necessary e.g. due to hypotension.
The enrolled patients will discontinue their prescribed ACEi/ARB. If hypertensive treatment is necessary during hospital admission the clinicians will first be encouraged to start non-ACEi/non-ARB treatment; however, if needed it will be possible to start ACEi/ARB again during hospital admission. After study completion (30 days from randomization) the patients will be reminded to seek their generel practitioner to reinitiate ACEi/ARB treatment.
The enrolled patients will continue their prescribed ACEi/ARB in the same dose.
The enrolled patients will discontinue their prescribed ACEi/ARB. If hypertensive treatment is necessary during the study period clinicians will first be encouraged to start non-ACEi/non-ARB treatment; however, if needed it will be possible to start ACEi/ARB again during the study period. After study completion (30 days from randomization) the patients will be reminded to seek their generel practitioner to reinitiate ACEi/ARB treatment.