Coronavirus (COVID-19) ACEi/ARB Investigation

NCT ID: NCT04330300

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 2414 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2021-12-01

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.

Conditions

Hypertension; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Alternative anti-hypertensive medication

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.

Group Type: EXPERIMENTAL

Thiazide or Thiazide-like diuretics

Intervention Type: DRUG

Anti-hypertensive (Active Arm)

Calcium Channel Blockers

Intervention Type: DRUG

Anti-hypertensive (Active Arm)

Continue ACEi/ARB antihypertensive

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.

Group Type: ACTIVE_COMPARATOR

ACE inhibitor

Intervention Type: DRUG

Anti-hypertensive (Control Arm)

Angiotensin receptor blocker

Intervention Type: DRUG

Anti-hypertensive (Control Arm)

Interventions

Thiazide or Thiazide-like diuretics

Anti-hypertensive (Active Arm)

Intervention Type: DRUG

Calcium Channel Blockers

Anti-hypertensive (Active Arm)

Intervention Type: DRUG

ACE inhibitor

Anti-hypertensive (Control Arm)

Intervention Type: DRUG

Angiotensin receptor blocker

Anti-hypertensive (Control Arm)

Intervention Type: DRUG

Other Intervention Names

Hydrochlorothiazide, metolazone, chlorthalidone, chlorothiazide, bendroflumethiazide, indapamide; Amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nimodipine, nitrendipine, verapamil; Benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril; Candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Prof. John William McEvoy

Professor of Preventive Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John William McEvoy, MBBCh MHS

Role: PRINCIPAL_INVESTIGATOR

National University of Ireland, Galway, Ireland

Locations

University Hospital Galway

Galway, , Ireland

Countries

Ireland

Other Identifiers

C.A. 2348

Identifier Type: -

Identifier Source: org_study_id