Cardiac Dysfunction in Critically Ill Patients With COVID-19 (CARDYCOVID)

Cardiac dysfunction has been reported to be common in patients infected with COVID-19. The aim of this study is to evaluate the clinical importance of cardiac dysfunction in critically ill patients infected with COVID-19.

Study Overview

• Status: Completed
• Conditions: Covid19; Pulmonary Hypertension; Right Ventricular Dysfunction; Left Ventricular Dysfunction
• Intervention / Treatment: Diagnostic test: Echocardiography

Detailed Description

Cardiac dysfunction has been reported to be common in patients infected with COVID-19. The aim of this study is to evaluate the clinical importance of cardiac dysfunction in critically ill patients with COVID-19. Patients admitted to the intensive care unit, with COVID-19 are examined with echocardiography for assessment of left and right ventricular dysfunction within 72 hours from admission and repeated after four to seven days.

Cardiac dysfunction was defined as having either left ventricular (LV) dysfunction, defined as having an ejection fraction <50% and/or regional hypokinesia, or right ventricular (RV) dysfunction, defined as having a tricuspid annular plane excursion (TAPSE) <17mm or a moderate/severe RV dysfunction assessed visually.

The cardiac biomarkers troponin and NTproBNP and clinical data are recorded at time of each echo. Mortality status is recorded at 30 days.

• Study Type: Observational
• Enrollment (Actual): 132

Contacts and Locations

Study Locations

• Sweden
  • Region Stockholm
    • Stockholm, Region Stockholm, Sweden
      • Södersjukhuset
  • Västra Götaland
    • Gothenburg, Västra Götaland, Sweden, 41345
      • Sahlgrenska University Hospital
    • Gothenburg, Västra Götaland, Sweden, 40530
      • Sahlgrenska University Hospital/Mölndal
    • Gothenburg, Västra Götaland, Sweden, 40530
      • Sahlgrenska University Hospital/Östra
  • Västra Götalandsregionen
    • Trollhättan, Västra Götalandsregionen, Sweden
      • North Älvsborg County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients admitted to participating unit, being infected with COVID-19 are eligible for inclusion

Description

Inclusion Criteria: Patients admitted to the intensive care unit infected with COVID-19

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All cause death in patients with vs without cardiac dysfunction	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular dysfunction	Prevalence of left ventricular dysfunction	Within 72 hours from admission
Right ventricular dysfunction	Prevalence of right ventricular dysfunction	Within 72 hours from admission
Risk-factors	Clinical variables associated with risk of having cardiac dysfunction	Within 72 hours from admission
Cardiac biomarkers	Levels of cardiac biomarkers in patients with vs without cardiac dysfunction	Within 72 hours from admission
Left ventricular dysfunction	Prevalence of left ventricular dysfunction	During ICU-stay
Right ventricular dysfunction	Prevalence of right ventricular dysfunction	During ICU-stay
Risk-factors	Clinical variables associated with risk of having cardiac dysfunction	During ICU-stay
Cardiac biomarkers	Levels of cardiac biomarkers in patients with vs without cardiac dysfunction	During ICU-stay

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Jonatan Oras, MD, PhD, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Hypertension; COVID-19; Hypertension, Pulmonary; Ventricular Dysfunction; Ventricular Dysfunction, Right; Ventricular Dysfunction, Left
• Other Study ID Numbers: CARDY CRIT COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No