Clinical trial NCT04390555: The Global PCHF-COVICAV Registry
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Cardiovascular Diseases
Cardiovascular Risk Factor
Heart Failure
Keywords: COVID-19
Cardiovascular Diseases
Cardiovascular Risk Factor
Heart Failure
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
First posted: 2020-05-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Age \<18 years old.
* Outpatients.

Primary outcomes:
measure: In-hospital mortality.
timeFrame: Hospitalization period, assessed up to 30 days
Secondary outcomes:
measure: The length of stay in the intensive care unit.
timeFrame: Hospitalization period in the ICU, assessed up to 30 days
measure: The duration of hospitalization.
timeFrame: Hospitalization period, assessed up to 30 days
measure: The need and duration of invasive mechanical ventilation.
timeFrame: Hospitalization period, assessed up to 30 days
measure: Hospitalization for cardiovascular causes or cardiovascular deaths within 3 months after hospitalization.
timeFrame: 3 months
measure: Hospitalization for cardiovascular causes or cardiovascular deaths within 6 months after hospitalization.
timeFrame: 6 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Zurich Heart Center, Unispital Zurich
Study officials:
affiliation: University Hospital Zurich, Zurich, Switzerland
name: Frank Ruschitzka, Prof. Dr. med
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Zurich, Switzerland
name: Andreas Flammer, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
affiliation: Wroclaw Medical University, Wroclaw, Poland
name: Mateusz Sokolski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.
citation: Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.
citation: Mehra MR, Desai SS, Kuy S, Henry TD, Patel AN. Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. 2020 Jun 18;382(25):e102. doi: 10.1056/NEJMoa2007621. Epub 2020 May 1.
citation: Cunningham JW, Ferreira JP, Deng H, Anker SD, Byra WM, Cleland JGF, Gheorghiade M, Lam CSP, La Police D, Mehra MR, Neaton JD, Spiro TE, van Veldhuisen DJ, Greenberg B, Zannad F. Natriuretic Peptide-Based Inclusion Criteria in a Heart Failure Clinical Trial: Insights From COMMANDER HF. JACC Heart Fail. 2020 May;8(5):359-368. doi: 10.1016/j.jchf.2019.12.009. Epub 2020 Mar 11.
citation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
citation: Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular Implications of Fatal Outcomes of Patients With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):811-818. doi: 10.1001/jamacardio.2020.1017.
citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
citation: Mehra MR, Ruschitzka F. COVID-19 Illness and Heart Failure: A Missing Link? JACC Heart Fail. 2020 Jun;8(6):512-514. doi: 10.1016/j.jchf.2020.03.004. Epub 2020 Apr 10. No abstract available.
citation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
citation: Varga Z, Flammer AJ, Steiger P, Haberecker M, Andermatt R, Zinkernagel AS, Mehra MR, Schuepbach RA, Ruschitzka F, Moch H. Endothelial cell infection and endotheliitis in COVID-19. Lancet. 2020 May 2;395(10234):1417-1418. doi: 10.1016/S0140-6736(20)30937-5. Epub 2020 Apr 21. No abstract available.