The Geneva Covid-19 CVD Study

Completed

• Conditions: COVID; CVD

• Registration Number: NCT04384029
• Lead Sponsor: François MACH

Brief Summary

In this study, the investigators propose to analyse the clinical data of all patients admitted in Geneva University Hospitals (HUG) or in a care center in Geneva who are diagnosed with COVID-19. CVD being one of the most important risk factors for developing a severe form of the disease, the investigators will explore the prognosis and clinical outcomes of those patients according to their CVD history as well as newly onset CVD during hospitalization. Moreover, as further evidence is needed on the use of renin-angiotensin-aldosterone system (RAAS) inhibitors for SARS-CoV-2 infected patients, the investigators will study prognosis and outcomes according to the patients' medications. Finally, the investigators propose to evaluate hospital length of stay and cost. The aim, therefore, is to collect information and scientific evidence from patients hospitalized and diagnosed positive for COVID-19, in order to evaluate if previous (or newly onset) CVD may influence outcomes and costs.

Detailed Description

Hypothesis:

COVID-19+ hospitalized patients with preexisting CVD or newly onset CVD at time of hospitalization have different clinical outcomes compared to those without CVD and COVID-19+.

Objectives:

The primary aim of this study is to gather observational data, starting from February 1st 2020 until the end of the pandemic, to compare clinical outcomes COVID+ hospitalized patients at HUG or in a care center in Geneva with pre-existing or newly onset CVD, to COVID+ hospitalized patients at HUG or in a care center in Geneva without pre-existing CVD.

The secondary aims of this study are:

* To determine the association between COVID-19 disease and CVD, based on: age, previous CV diseases, CV risks factors, CV medications (e.g. ACE Inhibitors or angiotensin II receptor antagonists)

* To explore CVD profiles that may influence COVID-19 disease outcomes

* To determine the cause of death in CVD patients (either with preexisting CVD or newly diagnosed with CVD)

* To understand the vulnerability of the myocardium (new event of either heart failure, acute coronary syndrome, arrhythmia, myocarditis) in patients with COVID-19 disease.

Study Timeline

• Study Start: 2020-03-24
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1927

Inclusion Criteria

• Subject is ≥18 years of age.
• Patient diagnosed SARS-CoV-2 positive at time of hospitalization.
• In case of the subject accepting the follow-up at 30 days and 1 year, Signed Patient Informed Consent (PIC) form

Exclusion Criteria

• Patients unwilling to provide informed consent for the follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality discharge	0 days after hospitalization	To compare mortality during hospital stay in COVID-19+ patients with or without preexisting CVD.
mortality 30 days after hospitalization	30 days after hospitalization	To comparemortality30 days after hospital stay in COVID-19+ patients with or without preexisting CVD.
mobidity discharge	0 days after hospitalization	To compare morbidity during hospital stay in COVID-19+ patients with or without preexisting CVD.
mobidity at 30 days	30 days after hospitalization	To compare morbidity 30 days after hospitalization in COVID-19+ patients with or without preexisting CVD.
mortality 1 year after hospitalization	1 year after hospitalization	To compare mortality 1 year after hospital stay in COVID-19+ patients with or without preexisting CVD.
mobidity 1 year after hospitalization	1 year after hospitalization	To compare morbidity 1 year after hospitalization stay in COVID-19+ patients with or without preexisting CVD.

Secondary Outcome Measures

Name	Time	Method
Cost of hospital stay	0 days after hospitalization	Cost of hospital stay
Clinical outcomes according to medication at admission	1 year after hospitalization	1 year after hospitalization
Clinical follow up at 30 days (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).	30 days after hospitalization	Clinical follow up at 30 days (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).
Clinical outcomes related to preexisting cardiovascular risk factors at admission	1 year after hospitalization	Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated 1 year after hospitalization
New onset of CVD induced by COVID-19 disease	1 year after hospitalization	New onset of CVD induced by COVID-19 disease at discharge evaluated 1 year after hospitalization
Clinical follow up at 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).	1 year after hospitalization	Clinical follow up at 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).

Trial Locations

Locations (1)

Geneva University Hospital (HUG); 🇨🇭 Geneva, Switzerland