NCT04020263 Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock
| NCT ID | NCT04020263 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pr Bruno LEVY |
| Condition | Cardiogenic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 610 participants |
| Start Date | 2023-07-03 |
| Primary Completion | 2027-02-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 610 participants in total. It began in 2023-07-03 with a primary completion date of 2027-02-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cardiogenic shock (CS) mortality remains high (40%). Despite their frequent use, few clinical outcome data are available to guide the initial selection of vasoactive drug therapies in patients with CS. Based on experts' opinions, the combination of norepinephrine-dobutamine is generally recommended as a first line strategy. Inotropic agents increase myocardial contractility, thereby increasing cardiac output. Dobutamine is commonly recommended to be the inotropic agent of choice and levosimendan is generally used following dobutamine failure. It may represent an ideal agent in cardiogenic shock, since it improves myocardial contractility without increasing cAMP or calcium concentration. At present, there are no convincing data to support a specific inotropic agent in patients with cardiogenic shock. Our hypothesis is that the early use of levosimendan, by enabling the discontinuation of dobutamine, would accelerate the resolution of signs of low cardiac output and facilitate myocardial recovery.
Eligibility Criteria
Inclusion Criteria: Adult patient ≥ 18 years with cardiogenic shock defined by: * Adequate intravascular volume * Norepinephrine to maintain MAP at least at 65 mmHg for at least 3 hours and less than 24h. At inclusion the dose must be \<1 microgram/kg/min under norepinephrine base or \<2 microgram/kg/min under norepinephrine tartrate, OR/AND Dobutamine since at least 3h and less than 24h at inclusion. * Tissue hypoperfusion: at least 1 sign within 24h prior to inclusion (lactate ≥ 2 mmol/l; mottling, capillary refeel time \> 3 seconds, oliguria \<500ml/24h or ≤ 20 ml/h during the last 2 hours, ScVO2 ≤ 60% or veno-arterial PCO2 gap ≥ 5 mmHg); Exclusion Criteria: * Myocardial sideration after cardiac arrest of non-cardiac etiology * Immediate or anticipated (within 6 hours) indication of Extra Corporel Life Support * Use of VA-ECMO or IMPELLA or LVAD; * Chronic renal failure requiring hemodialysis * Cardiotoxic poisoning * Septic cardiomyopathy * Previous levosimendan administration within 15 days * Cardiac arrest with non-shockable rhythm; * No flow time higher \> 3 minutes; * Cardiac arrest with unknown no flow duration; * Total duration of cardiac arrest (no flow plus low flow) \> 45 minutes; * Cerebral deficit with fixed dilated pupils * Patient moribund on the day of enrollment * Irreversible neurological pathology * Known hypersensitivity to levosimendan or placebo, or one of its excipients * Pregnant woman, birthing or breastfeeding mother * Minor (not emancipated) * Person deprived of liberty for judicial or administrative decision; * Adult subject to a legal protection measure (such as guardianship, conservatorship)
Contact & Investigator
Clément DELMAS, Dr
STUDY CHAIR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT04020263 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04020263 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 610 participants.
Is NCT04020263 currently recruiting?
Yes, NCT04020263 is actively recruiting participants. Contact the research team at b.levy@chru-nancy.fr for enrollment information.
Where is the NCT04020263 trial being conducted?
This trial is being conducted at Strasbourg, France, Marseille, France, Caen, France, Dijon, France and 11 additional locations.
Who is sponsoring the NCT04020263 clinical trial?
NCT04020263 is sponsored by Pr Bruno LEVY. The principal investigator is Clément DELMAS, Dr at University Hospital, Toulouse. The trial plans to enroll 610 participants.