Covid19CARDYCOVIDNCT04524234
Cardiac Dysfunction in Critically Ill Patients With COVID-19
An observational study of Covid19 and Left Ventricular Dysfunction, run by Sahlgrenska University Hospital at 5 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Covid19, Left Ventricular Dysfunction, Right Ventricular Dysfunction
- What is being tested?
- Echocardiography
- How many people
- 132 participants
- Where
- 5 sitesSweden
- Study dates
- 20 Apr 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: All patients admitted to participating unit, being infected with COVID-19 are eligible for inclusion
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Sahlgrenska University Hospital/Mölndal
Gothenburg, Västra Götaland County, 40530
Sahlgrenska University Hospital/Östra
Gothenburg, Västra Götaland County, 40530
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 41345
Södersjukhuset
Stockholm, Region Stockholm
North Älvsborg County Hospital
Trollhättan, Västra Götalandsregionen
About this study
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.
Read the 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.
- Conditions
- Covid19, Left Ventricular Dysfunction, Right Ventricular Dysfunction, Pulmonary Hypertension
- Being tested
- Echocardiography
- Medical subject headings
- COVID-19, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Echocardiography for assessment of cardiac function
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All cause death in patients with vs without cardiac dysfunction
Measured: 30 days
Secondary outcomes (8)
Left ventricular dysfunction
Prevalence of left ventricular dysfunction
Measured: Within 72 hours from admission
Right ventricular dysfunction
Prevalence of right ventricular dysfunction
Measured: Within 72 hours from admission
Risk-factors
Clinical variables associated with risk of having cardiac dysfunction
Measured: Within 72 hours from admission
Cardiac biomarkers
Levels of cardiac biomarkers in patients with vs without cardiac dysfunction
Measured: Within 72 hours from admission
Left ventricular dysfunction
Prevalence of left ventricular dysfunction
Measured: During ICU-stay
Right ventricular dysfunction
Prevalence of right ventricular dysfunction
Measured: During ICU-stay
Risk-factors
Clinical variables associated with risk of having cardiac dysfunction
Measured: During ICU-stay
Cardiac biomarkers
Levels of cardiac biomarkers in patients with vs without cardiac dysfunction
Measured: During ICU-stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start20 Apr 2020
- Primary completion31 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan Oras, Sahlgrenska University Hospital
- Investigators
- Jonatan Oras, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524234
- Sponsor's protocol ID
- CARDY CRIT COVID
- Acronym
- CARDYCOVID
- Status last verified
- Dec 2020
- First submitted
- 21 Aug 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Dysfunction in Critically Ill Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04524234
- Acronym / sponsor ID
- CARDYCOVID / CARDY CRIT COVID
- Conditions
- Covid19, Left Ventricular Dysfunction, Right Ventricular Dysfunction, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to participating unit, being infected with COVID-19 are eligible for inclusion
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyEchocardiography for assessment of cardiac function | Diagnostic test | – |
Primary outcome
Mortality
Time frame: 30 days
All cause death in patients with vs without cardiac dysfunction
8 secondary outcomes
Left ventricular dysfunction
Time frame: Within 72 hours from admission
Right ventricular dysfunction
Time frame: Within 72 hours from admission
Risk-factors
Time frame: Within 72 hours from admission
Cardiac biomarkers
Time frame: Within 72 hours from admission
Left ventricular dysfunction
Time frame: During ICU-stay
Right ventricular dysfunction
Time frame: During ICU-stay
Risk-factors
Time frame: During ICU-stay
Cardiac biomarkers
Time frame: During ICU-stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonatan Oras, MD, PhD principal investigator
Sahlgrenska University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Left Ventricular Dysfunction, run by Sahlgrenska University Hospital at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020; AzTrials last refreshed its copy on 30 Oct 2026.