Cardiogenic ShockPhase 3LEVOECMONCT04728932
LEVOSIMENDAN to Facilitate Weaning From ECMO in Severe Cardiogenic Shock Patients
A Phase 3 study testing Levosimendan in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation Complication, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
In the last decade, venoarterial extracorporeal membrane oxygenation (VA-ECMO) has become the first-line therapy in patients with refractory cardiogenic shock. VA-ECMO provides both respiratory and cardiac support, is easy to insert, even at the bedside, provides stable flow rates, and is associated with less organ… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Levosimendan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 3 sitesFrance
- Study dates
- 27 Aug 2021to 9 Nov 2024
- Phase
- Phase 3
- 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
- Acute cardiogenic shock patient refractory to conventional therapy placed on VA-ECMO support in the preceding 48h.
- Obtain informed consent from a close relative or surrogate. According to the specifications of emergency consent, randomization without the close relative or surrogate consent could be performed. Close relative/surrogate/family consent will be asked as soon as possible. The patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
Who cannot join
- Age <18
- Pregnant or lactating women
- Initiation of VA-ECMO >48 h
- Resuscitation >30 minutes in the 48 hours before ECMO (cumulative low-flow time). If a low-flow episode occurs before the 48 hours window prior to ECMO, patients must fully recover consciousness to be randomized.
- Irreversible neurological pathology
- End-stage cardiomyopathy with no hope of LV function recovery
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- Mechanical complication of myocardial infarction
- Aortic regurgitation > II
- VA-ECMO for pulmonary embolism
- VA-ECMO for cardiotoxic drug intoxication
- ECMO after left-ventricle assist device implantation
- VA-ECMO in heart transplant patients
- Patient moribund on the day of randomization, SAPS II >90
- Liver cirrhosis (Child B or C) and other severe hepatic insufficiency
- Chronic renal failure requiring hemodialysis
- Known hypersensitivity to levosimendan
- History of torsades de pointes in the 30 days prior to inclusion
- History of epilepsy
- Individuals under guardianship, or permanently legally incompetent adults
- Participation to another interventional study
- Patient with a weight over 180 kg
- Known hypersensitivity to polyvitamin CERNEVIT®
- In case of hypervitaminosis to any vitamin contained in this formulation,
- In case of severe hypercalcemia, hypercalciuria, treatment, pathology and/or disorders leading to severe hypercalcemia and/or hypercalciuria
- In combination with vitamin A or retinoids
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Pitié Salpêtrière
Paris, 75013
Hôpital Européen Georges Pompidou
Paris
Hôpital du Haut-Lévêque
Pessac, Bordeaux
About this study
In the last decade, venoarterial extracorporeal membrane oxygenation (VA-ECMO) has become the first-line therapy in patients with refractory cardiogenic shock. VA-ECMO provides both respiratory and cardiac support, is easy to insert, even at the bedside, provides stable flow rates, and is associated with less organ failure after implantation compared to large biventricular assist-devices that require open-heart surgery. In patients with potentially reversible cardiac failure (e.g. myocarditis, myocardial stunning post-myocardial infarction, post-cardiotomy or post-cardiac arrest), VA-ECMO might be weaned after a few days of support and used as a bridge to recovery.
Although considered as the ultimate life-saving technology for refractory cardiac failure, veno-arterial ECMO is still associated with severe complications. Specifically, excessive LV afterload and lack of LV unloading under VA-ECMO might induce LV stasis with thrombus formation, pulmonary edema, myocardial ischemia caused by ventricular distension and ultimately increase mortality. ECMO support also exposes to many complications such as infections, hemorrhage or peripheral vascular embolism. These complications are more frequent with prolonged support and are responsible for significant morbidity and mortality, prolonged ICU and hospital stays and higher costs.
Read more
Levosimendan, which acts to sensitize myocardial contractile proteins to calcium, improves cardiac contractility without increasing the intracellular calcium concentration. Unlike traditional inotropes such as dobutamine, levosimendan neither increases myocardial oxygen consumption nor impairs diastolic function or possess proarrhythmic effects. It also influences the opening of ATP-dependent potassium channels, including those in vascular smooth muscle cells, leading to coronary, pulmonary, and peripheral vasodilation and antiinflammatory, antioxidative, antiapoptotic, anti-stunning and cardioprotective effects. Additionally, Levosimendan which has a long lasting action (up to 7-9 d), resulting from the formation of active metabolite, may be used as a single 24h perfusion.
In recent preliminary studies, the drug was associated with accelerated weaning from VA-ECMO and even improved survival. Therefore, a multicenter randomized trial with sufficient statistical power is needed in refractory cardiogenic shock patients supported by VA-ECMO to test if the early administration of Levosimendan can facilitate and accelerate VA-ECMO weaning, and ultimately translate in significantly less morbidity, reduced ICU and hospital length of stays and associated costs.
- Being tested
- Levosimendan, Placebo of Levosimendan
- Keywords
- LEVOSIMENDAN
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
A continuous infusion of Levosimendan over 24h
Placebo of LevosimendanDrug
A continuous infusion of Placebo of Levosimendan over 24h
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Experimental | A continuous infusion of Levosimendan will be administered over 24 h, with no initial bolus. The starting infusion rate will be 0.15 µg/kg/min and will be increased to 0.20 µg/kg/min after 2 hours in the absence of rate-limiting side effects Receives: Drug: Levosimendan |
| Placebo | Placebo comparator | A continuous infusion of Placebo will be administered over 24 h, with no initial bolus. The starting infusion rate will be 0.15 µg/kg/min and will be increased to 0.20 µg/kg/min after 2 hours in the absence of rate-limiting side effects Receives: Drug: Placebo of Levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successful ECMO weaning within the 30 days following randomization
Measured: Day 30
Secondary outcomes (15)
Mortality
Measured: Day 30, Day 60
Total duration of ECMO support
Measured: Between inclusion and Day 30/Day 60
Number of ECMO-free days
Measured: Between inclusion and Day 30/Day 60
Duration of ICU stay
Measured: Between inclusion and Day 60
Duration of hospitalization stay
Measured: Between inclusion and Day 60
Major adverse cardiovascular events
defined as death, cardiac transplant, escalation to permanent left ventricular assist device, stroke, dialysis, re-hospitalization for heart failure
Measured: Day 30, Day 60
Time to improvement in hemodynamic parameters
Measured: Between inclusion and Day 60
Time to hemodynamic stabilization
Measured: Between inclusion and Day 60
Days with organ failure asessed by sequential organ failure assessment
Measured: Between inclusion and Day 30
Duration of hemodynamic support with catecholamines
Measured: Between inclusion and Day 30/Day 60
Number of days alive without hemodynamic support
Measured: Between inclusion and Day 30/Day 60
Duration of mechanical ventilation
Measured: Between inclusion and Day 30/Day 60
Number of days alive without mechanical ventilation
Measured: Between inclusion and Day 30/Day 60
Left ventricular function assessed with echocardiography
Measured: Day 30
Incidence of adverse drug reactions
Measured: Between inclusion and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start27 Aug 2021
- Primary completion9 Nov 2024
- Study completion9 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728932
- Sponsor's protocol ID
- P170914J
- Other IDs
- 2019-004319-29, 2019
- Acronym
- LEVOECMO
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Combes A, Saura O, Nesseler N, Lebbah S, Rozec B, Levy B, Fellahi JL, Beurton A, Meslin S, Gaudard P, Bougle A, Vincentelli A, Sonneville R, Lebreton G, Levy D, Ouattara A, Tubach F; LEVOECMO Trial Group and the International ECMO Network (ECMONet). Levosimendan to Facilitate Weaning From ECMO in Patients With Severe Cardiogenic Shock: The LEVOECMO Randomized Clinical Trial. JAMA. 2026 Jan 6;335(1):60-69. doi: 10.1001/jama.2025.19843.
PubMed 41324946
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEVOSIMENDAN to Facilitate Weaning From ECMO in Severe Cardiogenic Shock Patients
- ClinicalTrials.gov ID
- NCT04728932
- Acronym / sponsor ID
- LEVOECMO / P170914J
- Keywords
- LEVOSIMENDAN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 9 Nov 2024 (actual)
- Study completion
- 9 Nov 2024 (actual)
- First posted
- 28 Jan 2021 (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.
In the last decade, venoarterial extracorporeal membrane oxygenation (VA-ECMO) has become the first-line therapy in patients with refractory cardiogenic shock. VA-ECMO provides both respiratory and cardiac support, is easy to insert, even at the bedside, provides stable flow rates, and is associated with less organ failure after implantation compared to large biventricular assist-devices that require open-heart surgery. In patients with potentially reversible cardiac failure (e.g. myocarditis, myocardial stunning post-myocardial infarction, post-cardiotomy or post-cardiac arrest), VA-ECMO might be weaned after a few days of support and used as a bridge to recovery.
Although considered as the ultimate life-saving technology for refractory cardiac failure, veno-arterial ECMO is still associated with severe complications. Specifically, excessive LV afterload and lack of LV unloading under VA-ECMO might induce LV stasis with thrombus formation, pulmonary edema, myocardial ischemia caused by ventricular distension and ultimately increase mortality. ECMO support also exposes to many complications such as infections, hemorrhage or peripheral vascular embolism. These complications are more frequent with prolonged support and are responsible for significant morbidity and mortality, prolonged ICU and hospital stays and higher costs.
Levosimendan, which acts to sensitize myocardial contractile proteins to calcium, improves cardiac contractility without increasing the intracellular calcium concentration. Unlike traditional inotropes such as dobutamine, levosimendan neither increases myocardial oxygen consumption nor impairs diastolic function or possess proarrhythmic effects. It also influences the opening of ATP-dependent potassium channels, including those in vascular smooth muscle cells, leading to coronary, pulmonary, and peripheral vasodilation and antiinflammatory, antioxidative, antiapoptotic, anti-stunning and cardioprotective effects. Additionally, Levosimendan which has a long lasting action (up to 7-9 d), resulting from the formation of active metabolite, may be used as a single 24h perfusion.
In recent preliminary studies, the drug was associated with accelerated weaning from VA-ECMO and even improved survival. Therefore, a multicenter randomized trial with sufficient statistical power is needed in refractory cardiogenic shock patients supported by VA-ECMO to test if the early administration of Levosimendan can facilitate and accelerate VA-ECMO weaning, and ultimately translate in significantly less morbidity, reduced ICU and hospital length of stays and associated costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | Experimental | Drug: LevosimendanA continuous infusion of Levosimendan will be administered over 24 h, with no initial bolus. The starting infusion rate will be 0.15 µg/kg/min and will be increased to 0.20 µg/kg/min after 2 hours in the absence of rate-limiting side effects |
| Placebo | Placebo comparator | Drug: Placebo of LevosimendanA continuous infusion of Placebo will be administered over 24 h, with no initial bolus. The starting infusion rate will be 0.15 µg/kg/min and will be increased to 0.20 µg/kg/min after 2 hours in the absence of rate-limiting side effects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute cardiogenic shock patient refractory to conventional therapy placed on VA-ECMO support in the preceding 48h.
- Obtain informed consent from a close relative or surrogate. According to the specifications of emergency consent, randomization without the close relative or surrogate consent could be performed. Close relative/surrogate/family consent will be asked as soon as possible. The patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
Key exclusion criteria (25 listed)
- Age <18
- Pregnant or lactating women
- Initiation of VA-ECMO >48 h
- Resuscitation >30 minutes in the 48 hours before ECMO (cumulative low-flow time). If a low-flow episode occurs before the 48 hours window prior to ECMO, patients must fully recover consciousness to be randomized.
- Irreversible neurological pathology
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 |
|---|---|---|
| LevosimendanA continuous infusion of Levosimendan over 24h | Drug | Levosimendan |
| Placebo of LevosimendanA continuous infusion of Placebo of Levosimendan over 24h | Drug | Placebo |
Primary outcome
Time to successful ECMO weaning within the 30 days following randomization
Time frame: Day 30
15 secondary outcomes
Mortality
Time frame: Day 30, Day 60
Total duration of ECMO support
Time frame: Between inclusion and Day 30/Day 60
Number of ECMO-free days
Time frame: Between inclusion and Day 30/Day 60
Duration of ICU stay
Time frame: Between inclusion and Day 60
Duration of hospitalization stay
Time frame: Between inclusion and Day 60
Major adverse cardiovascular events
Time frame: Day 30, Day 60
Time to improvement in hemodynamic parameters
Time frame: Between inclusion and Day 60
Time to hemodynamic stabilization
Time frame: Between inclusion and Day 60
Days with organ failure asessed by sequential organ failure assessment
Time frame: Between inclusion and Day 30
Duration of hemodynamic support with catecholamines
Time frame: Between inclusion and Day 30/Day 60
Number of days alive without hemodynamic support
Time frame: Between inclusion and Day 30/Day 60
Duration of mechanical ventilation
Time frame: Between inclusion and Day 30/Day 60
Number of days alive without mechanical ventilation
Time frame: Between inclusion and Day 30/Day 60
Left ventricular function assessed with echocardiography
Time frame: Day 30
Incidence of adverse drug reactions
Time frame: Between inclusion and Day 60
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 21 Mar 2025.
- Derived from this study: PubMed 41324946Combes A, Saura O, Nesseler N, Lebbah S, Rozec B, Levy B, Fellahi JL, Beurton A, Meslin S, Gaudard P, Bougle A, Vincentelli A, Sonneville R, Lebreton G, Levy D, Ouattara A, Tubach F; LEVOECMO Trial Group and the International ECMO Network (ECMONet). Levosimendan to Facilitate Weaning From ECMO in Patients With Severe Cardiogenic Shock: The LEVOECMO Randomized Clinical Trial. JAMA. 2026 Jan 6;335(1):60-69. doi: 10.1001/jama.2025.19843.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levosimendan in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation Complication, run by Assistance Publique - Hôpitaux de Paris 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 25 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 21 Mar 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to successful ECMO weaning within the 30 days following randomization (time frame: Day 30). 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 NCT04728932, which also lists 1 linked publication.
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 Mar 2025.