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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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
Show all 25Show fewer
  • 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

Other trials in France

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 groups in NCT04728932
Study groupRoleWhat they receive
LevosimendanExperimentalA 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
PlaceboPlacebo comparatorA 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.

  1. Time to successful ECMO weaning within the 30 days following randomization

    Measured: Day 30

Secondary outcomes (15)
  1. Mortality

    Measured: Day 30, Day 60

  2. Total duration of ECMO support

    Measured: Between inclusion and Day 30/Day 60

  3. Number of ECMO-free days

    Measured: Between inclusion and Day 30/Day 60

  4. Duration of ICU stay

    Measured: Between inclusion and Day 60

  5. Duration of hospitalization stay

    Measured: Between inclusion and Day 60

  6. 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

  7. Time to improvement in hemodynamic parameters

    Measured: Between inclusion and Day 60

  8. Time to hemodynamic stabilization

    Measured: Between inclusion and Day 60

  9. Days with organ failure asessed by sequential organ failure assessment

    Measured: Between inclusion and Day 30

  10. Duration of hemodynamic support with catecholamines

    Measured: Between inclusion and Day 30/Day 60

  11. Number of days alive without hemodynamic support

    Measured: Between inclusion and Day 30/Day 60

  12. Duration of mechanical ventilation

    Measured: Between inclusion and Day 30/Day 60

  13. Number of days alive without mechanical ventilation

    Measured: Between inclusion and Day 30/Day 60

  14. Left ventricular function assessed with echocardiography

    Measured: Day 30

  15. 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.

  1. First posted28 Jan 2021
  2. Study start27 Aug 2021
  3. Primary completion9 Nov 2024
  4. Study completion9 Nov 2024

Resources

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)
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

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.

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