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Completed

NCT Number: NCT04384029

The Geneva Covid-19 CVD Study

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospital (HUG)

Geneva, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Covid-19 + patients

Other

all the patients hospitalized in Geneva and SARS-Cov2 positive

Primary outcomes

  1. mobidity discharge

    Time frame: 0 days after hospitalization

    To compare morbidity during hospital stay in COVID-19+ patients with or without preexisting CVD.

  2. mobidity at 30 days

    Time frame: 30 days after hospitalization

    To compare morbidity 30 days after hospitalization in COVID-19+ patients with or without preexisting CVD.

  3. mobidity 1 year after hospitalization

    Time frame: 1 year after hospitalization

    To compare morbidity 1 year after hospitalization stay in COVID-19+ patients with or without preexisting CVD.

  4. mortality discharge

    Time frame: 0 days after hospitalization

    To compare mortality during hospital stay in COVID-19+ patients with or without preexisting CVD.

  5. mortality 30 days after hospitalization

    Time frame: 30 days after hospitalization

    To comparemortality30 days after hospital stay in COVID-19+ patients with or without preexisting CVD.

  6. mortality 1 year after hospitalization

    Time frame: 1 year after hospitalization

    To compare mortality 1 year after hospital stay in COVID-19+ patients with or without preexisting CVD.

Secondary outcomes

  1. Clinical outcomes according to medication at admission

    Time frame: 0 days after hospitalization

    Clinical outcomes according to medication at admission evaluated at hospital discharge

  2. Clinical outcomes according to medication at admission

    Time frame: 30 days after hospitalization

    Clinical outcomes according to medication at admission evaluated 30 days after hospitalization

  3. Clinical outcomes according to medication at admission

    Time frame: 1 year after hospitalization

    1 year after hospitalization

  4. Clinical outcomes related to preexisting cardiovascular risk factors at admission

    Time frame: 0 days after hospitalization

    Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated after hospital discharge

  5. Clinical outcomes related to preexisting cardiovascular risk factors at admission

    Time frame: 30 days after hospitalization

    Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated 30 days after hospital discharge

  6. Clinical outcomes related to preexisting cardiovascular risk factors at admission

    Time frame: 1 year after hospitalization

    Clinical outcomes related to preexisting cardiovascular risk factors at admission evaluated 1 year after hospitalization

  7. New onset of CVD induced by COVID-19 disease

    Time frame: 0 days after hospitalization

    New onset of CVD induced by COVID-19 disease at discharge

  8. New onset of CVD induced by COVID-19 disease

    Time frame: 30 days after hospitalization

    New onset of CVD induced by COVID-19 disease evaluated 30 days after hospitalization

  9. New onset of CVD induced by COVID-19 disease

    Time frame: 1 year after hospitalization

    New onset of CVD induced by COVID-19 disease at discharge evaluated 1 year after hospitalization

  10. Cost of hospital stay

    Time frame: 0 days after hospitalization

    Cost of hospital stay

  11. Clinical follow up at 30 days (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).

    Time frame: 30 days after hospitalization

    Clinical follow up at 30 days (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).

  12. Clinical follow up at 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).

    Time frame: 1 year after hospitalization

    Clinical follow up at 1 year (diagnosis of new cardiac events, such as acute coronary syndromes, heart failure, arrhythmia, myocarditis).

Sponsors and collaborators

Lead sponsor

François MACH

Other

Registry information

Official study title

Retrospective Observational Study to Compare the Short, Mid- and Long-term Prognosis and Outcomes of SRAS-CoV-2 Infected Hospitalized Patients With Cardiovascular Disease (CVD) to SARS-CoV-2 Infected Hospitalized Patients Without CVD: The Geneva Covid-19 CVD Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 12, 2020
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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