The Global PCHF-COVICAV Registry

• Conditions: COVID-19; Cardiovascular Risk Factor; Heart Failure; Cardiovascular Diseases

• Registration Number: NCT04390555
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-30
• Status Verified: 2020-05
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-14
• Last Update Submitted: 2020-05-14
• Study First Posted: 2020-05-15
• Last Update Posted: 2020-05-15
• Primary Completion: 2020-12
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

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

Exclusion Criteria

• Age <18 years old.
• Outpatients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital mortality.	Hospitalization period, assessed up to 30 days	All-cause and cardiovascular mortality during index hospitalization.

Secondary Outcome Measures

Name	Time	Method
Hospitalization for cardiovascular causes or cardiovascular deaths within 3 months after hospitalization.	3 months
The duration of hospitalization.	Hospitalization period, assessed up to 30 days	The total length of stay in the hospital.
The length of stay in the intensive care unit.	Hospitalization period in the ICU, assessed up to 30 days	The duration of hospitalization on the intensive care unit.
The need and duration of invasive mechanical ventilation.	Hospitalization period, assessed up to 30 days
Hospitalization for cardiovascular causes or cardiovascular deaths within 6 months after hospitalization.	6 months

Trial Locations

Locations (1)

Zurich Heart Center, Unispital Zurich; 🇨🇭 Zurich, Switzerland