NCT04390555

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 6, 2020

Last Update Submit

May 14, 2020

Conditions

COVID-19Cardiovascular DiseasesCardiovascular Risk FactorHeart Failure

Keywords

COVID-19Cardiovascular DiseasesCardiovascular Risk FactorHeart Failure

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality.

    All-cause and cardiovascular mortality during index hospitalization.

    Hospitalization period, assessed up to 30 days

Secondary Outcomes (5)

  • The length of stay in the intensive care unit.

    Hospitalization period in the ICU, assessed up to 30 days

  • The duration of hospitalization.

    Hospitalization period, assessed up to 30 days

  • The need and duration of invasive mechanical ventilation.

    Hospitalization period, assessed up to 30 days

  • Hospitalization for cardiovascular causes or cardiovascular deaths within 3 months after hospitalization.

    3 months

  • Hospitalization for cardiovascular causes or cardiovascular deaths within 6 months after hospitalization.

    6 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Age \<18 years old.
  • Outpatients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zurich Heart Center, Unispital Zurich

Zurich, 8006, Switzerland

RECRUITING

Related Publications (10)

  • 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.

    PMID: 32125452BACKGROUND

  • 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.

    PMID: 32211816BACKGROUND

  • 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.

    PMID: 32356626BACKGROUND

  • 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.

    PMID: 32171760BACKGROUND

  • 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.

    PMID: 32171076BACKGROUND

  • 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.

    PMID: 32219356BACKGROUND

  • 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.

    PMID: 32031570BACKGROUND

  • 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.

    PMID: 32360242BACKGROUND

  • 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.

    PMID: 31986264BACKGROUND

  • 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.

    PMID: 32325026BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Cardiovascular DiseasesHeart Failure

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesHeart Diseases

Study Officials

  • Frank Ruschitzka, Prof. Dr. med

    University Hospital Zurich, Zurich, Switzerland

    STUDY DIRECTOR

  • Andreas Flammer, PD Dr. med

    University Hospital Zurich, Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

  • Mateusz Sokolski, MD, PhD

    Wroclaw Medical University, Wroclaw, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mateusz Sokolski, MD, PhD

CONTACT

+48717331112mateusz.sokolski@umed.wroc.pl

Sander Trenson, MD

CONTACT

+41442554939sander.trenson@usz.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 15, 2020

Study Start

April 30, 2020

Primary Completion

December 1, 2020

Study Completion

July 1, 2021

Last Updated

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)