Renin-Angiotensin-Aldosterone System Inhibitors, Hypertension, and COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background. Angiotensing converting enzyme type 2 (ACE2), a key enzyme of the renin-angiotensin-aldosterone system (RAAS), is the receptor of SARS-CoV-2 for cell entry into lungs. Because ACE2 may be modulated by RAAS inhibitors, such as angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs), there is concern that patients treated with ACEi and ARBs may be at higher risk for COVID-19 infection and severity.

Aim. To analyze the associations between COVID-19 and hypertension, and treatments with ACEi and ARBs.

Methods. In this retrospective observational study, consecutive patients hospitalized for suspected COVID-19 pneumonia will be divided into 2 groups, whether or not COVID-19 is confirmed. The two groups will be compared for baseline characteristics, mainly prior treatment with ACEi and ARBs, and clinical outcome at 1-month follow-up.

The main hypothesis is that ACEi and ARBs, which interact differently with ACE2, may have different relationships with COVID-19 infection or severity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Renin Angiotensin System - CoronaVirus

NCT04337008

COVID 19

UNKNOWN NA

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

NCT04351581

Covid-19

COMPLETED NA

Prognosis of Coronavirus Disease 2019 (COVID-19) Patients Receiving Receiving Antihypertensives

NCT04357535

COVID-19

COMPLETED

Renin-Angiotensin System Inhibitors and COVID-19

NCT04331574

COVID-19 Hypertension Cardiovascular Diseases

UNKNOWN

National Survey on Hypertension at Hospital

NCT00695266

Hypertension

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The coronavirus disease 2019 (Covid-19) pandemic is currently the main challenge facing healthcare providers. Data are lacking to guide clinical decision.

The renin-angiotensin-aldosterone system (RAAS) is a key process in cardiology. Its inhibition using angiotensin-converting enzyme inhibitors (ACEi) and angiotensin II type 1-receptor blockers (ARBs) is a cornerstone of the long-term management of arterial hypertension, heart failure and acute coronary syndrome. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) uses the angiotensin-converting enzyme 2 (ACE2) as a cellular entry receptor. ACE2 is part of the RAAS and is likely to be modulated by the use of ACEi and ARBs. Therefore, there is concern that patients who are treated with ACEi and ARBs may be at higher risk for Covid-19 infection.

However, little is known regarding how ACEi and ARBs could affect Covid-19 infection and severity. First, ACE2 may have a protective effect against lung injury because it degrades angiotensin II to angiotensin-(1-7). Second, the effect of RAAS inhibition on ACE2 expression has been poorly studied in humans. Third, ACE inhibitors and ARB have different effect on the RAAS and therefore their interaction with Covid-19 may differ.

The COVHYP study is designed to address part of these issues. This is an analytical retrospective observational study that will collect and analyze data regarding patients hospitalized with suspected Covid-19. We planned to screen for inclusion all consecutive patients referred form 10/03/2020 to 15/04/2020 to the emergency department of the Versailles Hospital, a tertiary center located in greater Paris area - one of the region most affected by Covid-19 in France through this period. The inclusion criteria are as follows: 1) Clinical presentation suggestive of COVID-19 pneumonia, at least fever or influenza-like syndrome AND cough or dyspnea; and 2) Test of the presence of SARS-CoV-2 RNA by RT-PCR in nasopharyngeal or sputum samples. Two groups of patients will be defined, those with confirmed Covid-19 pneumonia, and those without Covid-19. Hospital data will gathered, and patients or relatives will be contacted by phone for a one-month follow-up. We will compare baseline characteristics of patients, especially the previous treatment by ACEi or ARBs, in the two groups of patients, and evaluate whether these characteristics can be associated with diagnosis of SARS-CoV-2 infection and severity.

We hope that this study will provide a better understanding of the effect of RAAS inhibitors on Covid-19 pneumonia and its severity.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients with COVID-19

Patients with positive RT-PCR for SARS-CoV-2, and patients with négative RT-PCR for SARS-CoV-2 but clinical presentation highly suggestive of COVID-19, and typical COVID-19 abnormalities on chest CT-Scan.

No interventions assigned to this group

patients without COVID-19

Patients with négative RT-PCR for SARS-CoV-2 and chest CT-Scan or chest X-ray not suggestive of COVID-19

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age equal or more than 18;
* Symptoms suggestive of Covid-19 pneumonia. At least : fever \> 38°C or influenza-like illness (asthenia, myalgia, chills, muscular aches, …) AND cough or dyspnea;
* Hospitalization required on clinical criteria including: oxygen saturation \<96% without oxygen support, respiratory frequency \> 25 per minute, hemodynamic instability, medical history or comorbidities known at high risk for Covid-19 (chronic heart disease, congestive heart failure, chronic bronchopulmonary disease, diabetes mellitus, age\>70, history of cancer, immunosuppression, …);
* Covid-19 confirmation test performed (RT-PCR).