Coronavirus (COVID-19) ACEi/ARB Investigation
- Conditions
- HypertensionCOVID-19
- Interventions
- Drug: Thiazide or Thiazide-like diureticsDrug: ACE inhibitor
- Registration Number
- NCT04330300
- Lead Sponsor
- National University of Ireland, Galway, Ireland
- Brief Summary
Coronavirus disease 2019 (COVID-19) is a pandemic infection caused by a virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Because SARS-CoV-2 is known to require the angiotensin-converting enzyme 2 (ACE-2) receptor for uptake into the human body, there have been questions about whether medications that upregulate ACE-2 receptors might increase the risk of infection and subsequent complications. One such group of medications are anti-hypertensives that block the renin-angiotensin system, including both angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB). Both ACEi and ARB are widely used for the treatment of hypertension. Early reports from China and Italy suggest that many of those who die from COVID-19 have a coexisting history of hypertension. Consequently, there have been questions raised as to whether these 2 types of blood pressure medication might increase the risk of death among patients with COVID-19. However, it is well known that the prevalence of hypertension increases linearly with age. Therefore, it is possible that the high prevalence of hypertension and ACEi/ARB use among persons who die from COVID-19 is simply confounded by age (older people are at risk of both a history of hypertension and dying from COVID-19). Whether these commonly prescribed blood pressure medications increase the risk of COVID-19 or not remains unanswered. Statements from professional cardiology societies on both sides of the Atlantic have called for urgent research into this question. Our study aims to randomize patients with primary (essential) hypertension who are already taking ACEi/ARB to either switch to an alternative BP medication or continue with the ACEi/ARB that they have already been prescribed. Adults with compelling indications for ACEi/ARB will not be enrolled.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 2414
- Men and non-pregnant women aged 60 or over
- Known diagnosis of hypertension
- Current use of ACEi or ARB for the treatment of hypertension
- COVID-19 naïve (i.e. not known to be infected)
- English speaker
- Known diabetic nephropathy
- Known heart failure with reduced ejection fraction
- Resistant hypertension (defined as blood pressure that remains above goal despite concurrent use of three anti-hypertensive agents of different classes, one of which should be a diuretic, or as blood pressure that is controlled with four or more medications)
- Contraindications or allergies to CCB or Thiazide
- Unconscious patients
- Current psychiatric in-patients
- Patients in an emergency medical setting
- Inability to consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alternative anti-hypertensive medication Thiazide or Thiazide-like diuretics Switch to an alternative BP medication (specifically a Calcium channel blocker \[CCB\] or Thiazide/Thiazide-like diuretic at an equipotent blood pressure lowering dose). The choice of either CCB or Thiazide/Thiazide-like anti-hypertensive provided as alternative therapy will be at the discretion of the patient's treating physician. Alternative anti-hypertensive medication Calcium Channel Blockers Switch to an alternative BP medication (specifically a Calcium channel blocker \[CCB\] or Thiazide/Thiazide-like diuretic at an equipotent blood pressure lowering dose). The choice of either CCB or Thiazide/Thiazide-like anti-hypertensive provided as alternative therapy will be at the discretion of the patient's treating physician. Continue ACEi/ARB antihypertensive ACE inhibitor Continue with either the ACEi (Angiotensin Converting Enzyme Inhibitor) or the Angiotensin Receptor Blocker (ARB) that had already been prescribed for the treatment of hypertension. Continue ACEi/ARB antihypertensive Angiotensin receptor blocker Continue with either the ACEi (Angiotensin Converting Enzyme Inhibitor) or the Angiotensin Receptor Blocker (ARB) that had already been prescribed for the treatment of hypertension.
- Primary Outcome Measures
Name Time Method Number of Covid-19 positive participants who die, require intubation in ICU, or require hospitalization for non-invasive ventilation (NIV) 12 months Time from randomization to the first occurrence of any of the clinical events above
- Secondary Outcome Measures
Name Time Method Maximum troponin T value (ng/L) among Covid-19 positive participants who require acute hospitalization 12 months Number of Covid-19 positive participants who die 12 months Time from randomization to the first occurrence of above
Number of Covid-19 positive participants who require intubation in intensive care unit (ICU) 12 months Time from randomization to the first occurrence of above
Number of Covid-19 positive participants who require hospitalization for non-invasive ventilation (NIV) 12 months Time from randomization to the first occurrence of above
Number of SARS-CoV-2 positive participants 12 months Time from randomization to the first occurrence of above
24 hour mean systolic BP (mmHg) on ambulatory BP monitoring 12 months Performed in a random sub-sample of the cohort (both study arms)
All-cause mortality 12 months Time from randomization to the first occurrence of above
Trial Locations
- Locations (1)
University Hospital Galway
🇮🇪Galway, Ireland