Cardiovascular Physiological PhenomenaMYOLOADNCT06422481
Echocardiographic Measurement of Myocardial Work
A study testing Fluid administration and Norepinephrine administration or increase in norepinephrine dosage in people with Cardiovascular Physiological Phenomena and Intensive Care Unit Syndrome, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
Trial summary
Echocardiography is recommended for the hemodynamic management of patients with shock. Recently, a new echocardiographic method has been proposed that provides a non-invasive measurement of myocardial work incorporating different components, namely total myocardial work (GWI), constructive myocardial work (GCW), lost… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Physiological Phenomena, Intensive Care Unit Syndrome
- What is being tested?
- Fluid administration and Norepinephrine administration or increase in norepinephrine dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesFrance
- Study dates
- Jul 2024to Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- Indication to fluid administration left to the discretion of the attending physician
- Indication to norepinephrine administration or increase in norepinephrine dosage left to the discretion of the attending physician.
Who cannot join
- Patients under protection.
- Patients with do not ressuscitate order.
- Patients with severe left-side or right-side valvulopathy.
- Patients with atrial fibrillation.
- Patients with ventricular aneuvrysm or severe regional wall motion abnormalities.
- Patients with a pacemaker.
- Patients' objections to the collection of their health data.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Aphm Hopital La Timone
Marseille
CYRIL NAFATI, MD, CYRIL.NAFATI@AP-HM.fr
CYRIL NAFATI, MD
CHU de NICE ARCHET
Nice, CHU de Nice, 06000
Mathieu Jozwiak, MD, +33492035510, jozwiak.m@chu-nice.fr
THOMAS CITTI
CHU de NICE PASTEUR
Nice, CHU de Nice, 06000
DENIS DOYEN, MD, doyen.d@chu-nice.fr
DENIS DOYEN, MD
About this study
Official title: Non-invasive Measurement of Myocardial Work Using Transthoracic Echocardiography in Critically Ill Patients: the MYOLOAD Study
Echocardiography is recommended for the hemodynamic management of patients with shock. Recently, a new echocardiographic method has been proposed that provides a non-invasive measurement of myocardial work incorporating different components, namely total myocardial work (GWI), constructive myocardial work (GCW), lost myocardial work (GWW) and effective myocardial work (GWE). Echocardiographic measurement of myocardial work takes into account both myocardial deformation and left ventricular afterload (estimated by measuring systolic blood pressure) and, unlike the measurement of left ventricular ejection fraction and global longitudinal strain, could be less dependent on cardiac load conditions, particularly left ventricular afterload. To date, non-invasive measurement of myocardial work has never been validated in critically ill patients, and no study has assessed the effects of different therapies (fluids administration, administration of norepinephrine) on the different components of myocardial work in patients admitted to intensive care unit.
- Being tested
- Fluid administration, Norepinephrine administration or increase in norepinephrine dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid administrationOther
Patients will receive fluid administration (500 mL of saline over 30 minutes). The indication of fluid administration will be left to the discretion of the attending physician.
Norepinephrine administration or increase in norepinephrine dosageOther
Patients will receive norepinephrine or norepinephrine dosage will be increased if necessary to achieve the appropriate mean arterial pressure level. The indication of norepinephrine administration or increase in norepinephrine dosage will be left to the discretion of the attending physician.
| Study group | Role | What they receive |
|---|---|---|
| Fluids | Experimental | Not described Receives: Other: Fluid administration |
| Norepinephrine | Experimental | Not described Receives: Other: Norepinephrine administration or increase in norepinephrine dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of echocardiographic measurement
The primary outcome will be assess by evaluating the proportion of patients in whom non-invasive echocardiographic measurement of myocardial work is obtained.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
measurement of myocardial by cardiac ultrasound during fluid administration
The measurement of myocardial work will be performed non-invasively by cardiac ultrasound.
The secondary outcomes will be assess the impact of fluid administration on the different components of myocardial work. as follows:
(i) fluid-induced changes in the different components of myocardial work, (ii) concordance between changes in myocardial work and changes in cardiac output induced by fluid administration (iii), the ability of the different components of myocardial work to predict fluid responsiveness.
Measured: through study completion, an average of 1 year
measurement of myocardial by cardiac ultrasound norepinephrine administration
The measurement of myocardial work will be performed non-invasively by cardiac ultrasound.
The secondary outcomes will be assess the impact of norepinephrine administration on the different components of myocardial work. as follows:
(i) norepinephrine-induced changes in the different components of myocardial work, (ii) concordance between changes in myocardial work and changes in cardiac output induced by norepinephrine and (iii), the ability of the different components of myocardial work to predict fluid responsiveness.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study startJul 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Physiological PhenomenaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422481
- Sponsor's protocol ID
- 24-PP-04
- Acronym
- MYOLOAD
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Measurement of Myocardial Work Using Transthoracic Echocardiography in Critically Ill Patients: the MYOLOAD Study
- ClinicalTrials.gov ID
- NCT06422481
- Acronym / sponsor ID
- MYOLOAD / 24-PP-04
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 May 2024 (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.
Echocardiography is recommended for the hemodynamic management of patients with shock. Recently, a new echocardiographic method has been proposed that provides a non-invasive measurement of myocardial work incorporating different components, namely total myocardial work (GWI), constructive myocardial work (GCW), lost myocardial work (GWW) and effective myocardial work (GWE). Echocardiographic measurement of myocardial work takes into account both myocardial deformation and left ventricular afterload (estimated by measuring systolic blood pressure) and, unlike the measurement of left ventricular ejection fraction and global longitudinal strain, could be less dependent on cardiac load conditions, particularly left ventricular afterload. To date, non-invasive measurement of myocardial work has never been validated in critically ill patients, and no study has assessed the effects of different therapies (fluids administration, administration of norepinephrine) on the different components of myocardial work in patients admitted to intensive care unit.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluids | Experimental | Other: Fluid administration |
| Norepinephrine | Experimental | Other: Norepinephrine administration or increase in norepinephrine dosage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication to fluid administration left to the discretion of the attending physician
- Indication to norepinephrine administration or increase in norepinephrine dosage left to the discretion of the attending physician.
Key exclusion criteria (7 listed)
- Patients under protection.
- Patients with do not ressuscitate order.
- Patients with severe left-side or right-side valvulopathy.
- Patients with atrial fibrillation.
- Patients with ventricular aneuvrysm or severe regional wall motion abnormalities.
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 |
|---|---|---|
| Fluid administrationPatients will receive fluid administration (500 mL of saline over 30 minutes). The indication of fluid administration will be left to the discretion of the attending physician. | Other | Fluids |
| Norepinephrine administration or increase in norepinephrine dosagePatients will receive norepinephrine or norepinephrine dosage will be increased if necessary to achieve the appropriate mean arterial pressure level. The indication of norepinephrine administration or increase in norepinephrine dosage will be left to the discretion of the attending physician. | Other | Norepinephrine |
Primary outcome
Determine the feasibility of echocardiographic measurement
Time frame: through study completion, an average of 1 year
The primary outcome will be assess by evaluating the proportion of patients in whom non-invasive echocardiographic measurement of myocardial work is obtained.
2 secondary outcomes
measurement of myocardial by cardiac ultrasound during fluid administration
Time frame: through study completion, an average of 1 year
measurement of myocardial by cardiac ultrasound norepinephrine administration
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid administration and Norepinephrine administration or increase in norepinephrine dosage in people with Cardiovascular Physiological Phenomena and Intensive Care Unit Syndrome, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
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 7 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: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu Jozwiak, MD (+33492035510, jozwiak.m@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the feasibility of echocardiographic measurement (time frame: through study completion, an average of 1 year). 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 21 May 2024.