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Using levosimendan to treat cardiogenic shock

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

Phase 3 Interventional Central Hospital, Nancy, France · NCT04020263

This study is testing if giving levosimendan early can help adults with cardiogenic shock feel better and improve their chances of survival compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment610 (estimated)
Ages18 Years and up
SexAll
SponsorCentral Hospital, Nancy, France Academic / other
Locations28 sites (Strasbourg, Bas-Rhin and 27 other locations)
Trial IDNCT04020263 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of early administration of levosimendan compared to a placebo in patients experiencing cardiogenic shock. The study aims to determine if levosimendan can improve outcomes by enhancing myocardial contractility without the adverse effects associated with traditional inotropic therapies. Participants will be adults with cardiogenic shock who have been stabilized with norepinephrine and/or dobutamine. The trial will assess the impact of levosimendan on morbidity and mortality rates in this high-risk population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with cardiogenic shock requiring inotropic support.

Not a fit: Patients with cardiogenic shock due to non-cardiac causes or those requiring immediate advanced life support interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality and improve recovery in patients with cardiogenic shock.

How similar studies have performed: While there is limited data on the specific use of levosimendan in this context, other studies have explored inotropic agents in cardiogenic shock with varying results, making this approach both relevant and potentially novel.

Eligibility criteria

Show full inclusion / exclusion 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)

Where this trial is running

Strasbourg, Bas-Rhin and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cardiogenic Shockheart failurelevosimendan
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.