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The Global PCHF-COVICAV Registry (PCHF-COVICAV)

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ClinicalTrials.gov Identifier: NCT04390555
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
Wroclaw Medical University
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

Background: Coronavirus disease (COVID-19) is a tremendous challenge the modern world has never seen before and is overwhelming the capacities of healthcare systems worldwide. Patients with cardiovascular diseases, heart failure in particular, and cardiovascular risk factors seem to be at a very high risk if affected by COVID-19 - and vice versa there are more and more reports of cardiac manifestations with the viral disease.

Aim: The purpose of the study is to characterise the clinical course of adult inpatients with COVID-19 and concomitant cardiovascular affection in a worldwide, multicentre PCHF registry.

Methods: Retrospective and prospective data analysis. Data on demographic, clinical, selected laboratory, electrocardiography and echocardiography parameters, treatment and outcome will be collected. The principal investigator provides dedicated electronic case report form. The primary outcome is in-hospital mortality. The secondary endpoints will be ICU length of stay, hospital length of stay, the need and duration of invasive mechanical ventilation, cardiovascular hospitalisation after 3 and 6 months from index hospitalisation, all-cause and cardiovascular mortality after 3 and 6 months from index hospitalisation.


Condition or disease
COVID-19 Cardiovascular Diseases Cardiovascular Risk Factor Heart Failure

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 6 Months
Official Title: COVID-19 in Hospitalised Patients With Preexisting CArdioVascular Diseases and/or Cardiac Involvement and/or Cardiovascular Risk Factors: the Global PCHF-COVICAV Registry
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Group/Cohort
CV involvement
Patients with COVID-19 and preexisting cardiovascular diseases and/or cardiovascular risk factors (diabetes mellitus, arterial hypertension and/or dyslipidaemia).
Control
Patients with COVID-19 without preexisting cardiac involvement.



Primary Outcome Measures :
  1. In-hospital mortality. [ Time Frame: Hospitalization period, assessed up to 30 days ]
    All-cause and cardiovascular mortality during index hospitalization.


Secondary Outcome Measures :
  1. The length of stay in the intensive care unit. [ Time Frame: Hospitalization period in the ICU, assessed up to 30 days ]
    The duration of hospitalization on the intensive care unit.

  2. The duration of hospitalization. [ Time Frame: Hospitalization period, assessed up to 30 days ]
    The total length of stay in the hospital.

  3. The need and duration of invasive mechanical ventilation. [ Time Frame: Hospitalization period, assessed up to 30 days ]
  4. Hospitalization for cardiovascular causes or cardiovascular deaths within 3 months after hospitalization. [ Time Frame: 3 months ]
  5. Hospitalization for cardiovascular causes or cardiovascular deaths within 6 months after hospitalization. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult inpatients (≥18 years old) with laboratory-confirmed COVID-19. Subjects with pre-existing cardiovascular disease and/or cardiac manifestations of COVID-19 infection (heart failure, acute coronary syndrome, myocarditis, arrhythmias, sudden cardiac arrest) and/or cardiovascular risk factors (dyslipidemia, hypertension, diabetes) are the focus of the study. Hospitalised subjects with COVID-19, but without cardiovascular disease or risk factors, will be used as a control population.
Criteria

Inclusion Criteria:

  • Adult inpatients (≥18 years old) with laboratory-confirmed COVID-19.

Exclusion Criteria:

  • Age <18 years old.
  • Outpatients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390555


Contacts
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Contact: Mateusz Sokolski, MD, PhD +48717331112 mateusz.sokolski@umed.wroc.pl
Contact: Sander Trenson, MD +41442554939 sander.trenson@usz.ch

Locations
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Switzerland
Zurich Heart Center, Unispital Zurich Recruiting
Zurich, Switzerland, 8006
Sponsors and Collaborators
University of Zurich
Wroclaw Medical University
Investigators
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Study Director: Frank Ruschitzka, Prof. Dr. med University Hospital Zurich, Zurich, Switzerland
Principal Investigator: Andreas Flammer, PD Dr. med University Hospital Zurich, Zurich, Switzerland
Principal Investigator: Mateusz Sokolski, MD, PhD Wroclaw Medical University, Wroclaw, Poland
Additional Information:
Publications:

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04390555    
Other Study ID Numbers: PCHF-COVICAV
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
COVID-19
Cardiovascular Diseases
Cardiovascular Risk Factor
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Heart Diseases