ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic

NCT ID: NCT04329195

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-09
• Study Completion Date: 2021-01-09

Brief Summary

Since December 2019, a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19.

Individuals with a history of cardiovascular disease develop a more severe illness and have higher rates of death.

Because of the potential interaction between RAS blockers and SARS-CoV-2 mechanism of infection, there are ongoing scientific discussions on whether they should be stopped or continued in patients with COVID-19.

It is crucial to determine whether RAS blockers should be discontinued or not in patients with COVID-19.

Conditions

History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection

Study Design

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

Study Groups

1: discontinuation of RAS blocker therapy

discontinuation of RAS blocker therapy

Group Type: EXPERIMENTAL

1: discontinuation of RAS blocker therapy

Intervention Type: DRUG

discontinuation of RAS blocker therapy

2: continuation of RAS blocker therapy

continuation of RAS blocker therapy

Group Type: ACTIVE_COMPARATOR

2: continuation of RAS blocker therapy

Intervention Type: DRUG

continuation of RAS blocker therapy

Interventions

1: discontinuation of RAS blocker therapy

discontinuation of RAS blocker therapy

Intervention Type: DRUG

2: continuation of RAS blocker therapy

continuation of RAS blocker therapy

Intervention Type: DRUG

Other Intervention Names

discontinuation of RAS blocker therapy; continuation of RAS blocker therapy

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old.
• Chronically treated with RAS blockers (ACE inhibitors or ARBs on the last prescription prior to admission with a treatment duration ≥ 1 month).
• Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample with any detection method.
• Patients hospitalized in a non-intensive care unit.
• Pregnancy test at inclusion visit for women of childbearing potential.
• Women of childbearing potential must agree to use adequate contraception according to recommendations related to contraception and pregnancy testing in clinical trials, by Clinical Trial Facilitation Group (CTFG).

Exclusion Criteria

• Shock requiring vasoactive agents.
• Acute respiratory distress syndrome requiring invasive mechanical ventilation.
• Circulatory assistance.
• History of malignant hypertension according to the definition of the 2018 ESC/ESH guidelines on hypertension.
• Uncontrolled blood pressure despite the use of five antihypertensive drugs.
• History of nephrotic syndrome.
• History of hospitalization for hemorrhagic stroke in the past 3 months.
• RAS blockers therapy previously stopped > 48h.
• No affiliation to the French Health Care System "Sécurité Sociale".
• Inability to obtain informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier Pitié-Salpêtrière

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles MONTALESCOT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Cardiologie - Pitié Salpêtrière(APHP) / ACTION Study Group / Univ. Paris 6 (UPMC) - INSERM UMRS 1166

Locations

Cardiologie, Groupe Hospitalier Pitié-Salpêtrière

Paris, , France

Countries

France

Other Identifiers

APHP200409

Identifier Type: -

Identifier Source: org_study_id