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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04524234
Recruitment Status : Completed
First Posted : August 24, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Jonatan Oras, Sahlgrenska University Hospital, Sweden

Brief Summary:
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.

Condition or disease Intervention/treatment
Covid19 Left Ventricular Dysfunction Right Ventricular Dysfunction Pulmonary Hypertension 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 infected with COVID-19. Patients admitted to the intensive care unit, being infected with COVID-19 are examined with echocardiography for assessment of left and right ventricular dysfunction. Clinical data and mortality status are recorded.

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Study Type : Observational
Actual Enrollment : 133 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Dysfunction in Critically Ill Patients Infected With COVID-19
Actual Study Start Date : April 20, 2020
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Echocardiography
    Echocardiography for assessment of cardiac function


Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    All cause death in patients with vs without cardiac dysfunction


Secondary Outcome Measures :
  1. Left ventricular dysfunction [ Time Frame: Within 72 hours from admission ]
    Prevalence of left ventricular dysfunction

  2. Right ventricular dysfunction [ Time Frame: Within 72 hours from admission ]
    Prevalence of right ventricular dysfunction

  3. Risk-factors [ Time Frame: Within 72 hours from admission ]
    Clinical variables associated with risk of having cardiac dysfunction

  4. Cardiac biomarkers [ Time Frame: Within 72 hours from admission ]
    Levels of cardiac biomarkers in patients with vs without cardiac dysfunction

  5. Left ventricular dysfunction [ Time Frame: During ICU-stay ]
    Prevalence of left ventricular dysfunction

  6. Right ventricular dysfunction [ Time Frame: During ICU-stay ]
    Prevalence of right ventricular dysfunction

  7. Risk-factors [ Time Frame: During ICU-stay ]
    Clinical variables associated with risk of having cardiac dysfunction

  8. Cardiac biomarkers [ Time Frame: During ICU-stay ]
    Levels of cardiac biomarkers in patients with vs without cardiac dysfunction


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes 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
Criteria

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

Exclusion Criteria:

-


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): NCT04524234


Locations
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Sweden
Södersjukhuset
Stockholm, Region Stockholm, Sweden
North Älvsborg County Hospital
Trollhättan, Västra Götalandsregionen, Sweden
Sahlgrenska University Hospital/Mölndal
Gothenburg, Västra Götaland, Sweden, 40530
Sahlgrenska University Hospital
Gothenburg, Västra Götaland, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Jonatan Oras, MD, PhD Sahlgrenska University Hospital, Sweden
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Responsible Party: Jonatan Oras, Associate professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04524234    
Other Study ID Numbers: CARDY-COVID
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Ventricular Dysfunction
Ventricular Dysfunction, Left
Ventricular Dysfunction, Right
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases