Status:

COMPLETED

Effects of Discontinuing Renin-angiotensin System Inhibitors in Patients With and Without COVID-19

Lead Sponsor:

University Hospital, Gentofte, Copenhagen

Conditions:

Covid-19

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Recent data from some of the earliest and worst affected countries of COVID-19 suggest a major overrepresentation of hypertension and diabetes among COVID-19-related deaths and among patients experien...

Eligibility Criteria

Inclusion

  • Group A and B
  • Verified COVID-19
  • Hospital admitted
  • Daily administration of RAS-inhibiting therapy
  • Age 18 years and above
  • Informed consent

Exclusion

  • 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

Key Trial Info

Start Date :

May 18 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 22 2022

Estimated Enrollment :

78 Patients enrolled

Trial Details

Trial ID

NCT04351581

Start Date

May 18 2020

End Date

December 22 2022

Last Update

January 18 2023

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Department of Medicine, Gentofte Hospital, University of Copenhagen

Hellerup, Capital Region of Denmark, Denmark, 2900

2

Department of Medicine, Herlev Hospital, University of Copenhagen

Herlev, Capital Region of Denmark, Denmark, 2730