Left Ventricular DysfunctionLEVEDYCIPNCT03787810
Left Ventricular Dysfunction in Critically Ill Patients
An observational study of Left Ventricular Dysfunction and Critically Ill, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Left ventricular dysfunction is common in the critically ill. The aim of this study is to assess the incidence and prognosis of left ventricular dysfunction in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dysfunction, Critically Ill, Acute Coronary Syndrome
- What is being tested?
- Echocardiography
- How many people
- 428 participants
- Where
- 1 siteSweden
- Study dates
- 28 May 2018to 20 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General ICU population
Who may be able to join
- Admitted within 24 hours to the ICU
- Dysfunction of at least one organ system, defined as at least +1 point in SOFA-score.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götalandsregionen, 41345
About this study
Left ventricular dysfunction is common in the critically ill. The aim of this study is to assess the incidence and prognosis of left ventricular dysfunction in critically ill patients.
Read the detailed description
Left ventricular dysfunction is common in the critically ill. A number of conditions can cause left ventricular dysfunction including myocardial infarction, septic cardiomyopathy, post resuscitation syndrome, takotsubo syndrome etc. A number of studies have assessed cardiac dysfunction in specific conditions (e.g. sepsis, cardiac arrest) but only a few studies have assessed cardiac dysfunction in a general ICU-population. The study will focus on diagnostics of the different types of cardiomyopathy and differentiating between ischemic and non-ischemic left ventricular dysfunction in a general ICU population. The aim of this study is to assess the incidence and prognosis of the different types of left ventricular dysfunction in critically ill patients. Our hypothesis is that left ventricular dysfunction is common in the critically ill and is associated with an increased risk of short-term death.
- Conditions
- Left Ventricular Dysfunction, Critically Ill, Acute Coronary Syndrome, Cardiomyopathies, Takotsubo Cardiomyopathy
- Being tested
- Echocardiography
- Medical subject headings
- Ventricular Dysfunction, Left, Critical Illness, Acute Coronary Syndrome, Cardiomyopathies, Takotsubo Cardiomyopathy
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 left ventricular dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All cause mortality after admission to the ICU
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start28 May 2018
- Primary completion20 Feb 2019
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular DysfunctionStudies 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
- 428 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 Academy, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787810
- Sponsor's protocol ID
- LEVEDYCIP
- Acronym
- LEVEDYCIP
- Status last verified
- Sep 2019
- First submitted
- 23 Dec 2018
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided
Publications
Cavefors O, Bech-Hanssen O, Redfors B, Oras J. Echocardiographic assessment of left ventricular longitudinal function in critically ill patients. Crit Care. 2026 Jul 10;30(1):365. doi: 10.1186/s13054-026-06193-5.
PubMed 42432793Cavefors O, Ljung Faxen U, Bech-Hanssen O, Lundin S, Ricksten SE, Redfors B, Oras J. Isolated diastolic dysfunction is associated with increased mortality in critically ill patients. J Crit Care. 2023 Aug;76:154290. doi: 10.1016/j.jcrc.2023.154290. Epub 2023 Mar 20.
PubMed 36947970
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Dysfunction in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03787810
- Acronym / sponsor ID
- LEVEDYCIP / LEVEDYCIP
- Conditions
- Left Ventricular Dysfunction, Critically Ill, Acute Coronary Syndrome, Cardiomyopathies, Takotsubo Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 26 Dec 2018 (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.
Left ventricular dysfunction is common in the critically ill. The aim of this study is to assess the incidence and prognosis of left ventricular dysfunction in critically ill patients.
Detailed description
Left ventricular dysfunction is common in the critically ill. A number of conditions can cause left ventricular dysfunction including myocardial infarction, septic cardiomyopathy, post resuscitation syndrome, takotsubo syndrome etc. A number of studies have assessed cardiac dysfunction in specific conditions (e.g. sepsis, cardiac arrest) but only a few studies have assessed cardiac dysfunction in a general ICU-population. The study will focus on diagnostics of the different types of cardiomyopathy and differentiating between ischemic and non-ischemic left ventricular dysfunction in a general ICU population. The aim of this study is to assess the incidence and prognosis of the different types of left ventricular dysfunction in critically ill patients. Our hypothesis is that left ventricular dysfunction is common in the critically ill and is associated with an increased risk of short-term death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General ICU population
Key inclusion criteria (2 listed)
- Admitted within 24 hours to the ICU
- Dysfunction of at least one organ system, defined as at least +1 point in SOFA-score.
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 left ventricular dysfunction | Diagnostic test | – |
Primary outcome
Mortality
Time frame: 30 days
All cause mortality after admission to the ICU
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 Apr 2020.
- Derived from this study: PubMed 42432793Cavefors O, Bech-Hanssen O, Redfors B, Oras J. Echocardiographic assessment of left ventricular longitudinal function in critically ill patients. Crit Care. 2026 Jul 10;30(1):365. doi: 10.1186/s13054-026-06193-5.
- Derived from this study: PubMed 36947970Cavefors O, Ljung Faxen U, Bech-Hanssen O, Lundin S, Ricksten SE, Redfors B, Oras J. Isolated diastolic dysfunction is associated with increased mortality in critically ill patients. J Crit Care. 2023 Aug;76:154290. doi: 10.1016/j.jcrc.2023.154290. Epub 2023 Mar 20.
- Individual participant dataSharing planned: Undecided. Not decided
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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 Academy, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Dysfunction and Critically Ill, run by Sahlgrenska University Hospital at 1 site 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 2 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 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
On the ClinicalTrials.gov record for NCT03787810, which also lists 2 linked publications.
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 Apr 2020.