Tests early levosimendan with usual heart-support drugs in cardiogenic shock
Tests early levosimendan, compared with placebo, for adults with cardiogenic shock.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Ars-Laquenexy, Avignon, Besançon, Bordeaux, Bron, Caen, Créteil, Dijon, La Tronche, Lille, Limoges, Marseille, Montpellier, Nantes, Nîmes, Paris, Rennes, Rouen, Strasbourg, Toulouse, and Vandœuvre-lès-Nancy, FranceSee the 27 sites
- Phase
- Phase 3
Where in France
- CHR Metz-Thionville, Mercy HospitalArs-Laquenexy, FranceTaking people
- CH Henri Duffaut AvignonAvignon, FranceNot yet recruiting
- CHU Besançon Jean Minjoz HospitalBesançon, FranceTaking people
- CHU BordeauxBordeaux, FranceTaking people
- CHU Bordeaux - Hopital Haut-LévèqueBordeaux, FranceTaking people
- Hospices Civils de Lyon - Louis Pradel HospitalBron, FranceTaking people
- CHU CaenCaen, FranceNot yet recruiting
- APHP, Henri Mondor HospitalCréteil, FranceTaking people
- HENRI MONDOR -réanimationCréteil, FranceNot yet recruiting
- CHU DijonDijon, FranceTaking people
- CHU Grenoble -USICLa Tronche, FranceTaking people
- CHU Grenoble, Michallon HospitalLa Tronche, FranceTaking people
- CHRU Lille, Cœur Poumon InstituteLille, FranceTaking people
- CHU Limoges, Dupuytren HospitalLimoges, FranceTaking people
- AP-HM CHU La TimoneMarseille, FranceTaking people
- AP-HM, Nord Hospital, MarseilleMarseille, FranceTaking people
- Chu Montpellier Hopital Arnaud de VilleneuveMontpellier, FranceTaking people
- CHU Montpellier, Arnaud de Villeneuve HospitalMontpellier, FranceTaking people
- CHU NantesNantes, FranceTaking people
- CHU Nîmes, Carémeau HospitalNîmes, FranceTaking people
- APHP, La Pitié Salpêtrière (medical intensive care unit)Paris, FranceTaking people
- CHU Rennes - Pontchaillou HospitalRennes, FranceTaking people
- CHU RouenRouen, FranceTaking people
- Chru Strasbourg - Nouvel Hopital CivilStrasbourg, FranceTaking people
- HU Strasbourg USICStrasbourg, FranceNot yet recruiting
- CHU de ToulouseToulouse, FranceTaking people
- CHRU NancyVandœuvre-lès-Nancy, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pr Bruno LEVY
- Trial code
- NCT04020263EU 2024-513811-29-00
- Record updated
- 5 August 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Previous levosimendan administration within 15 days; Myocardial sideration after cardiac arrest of non-cardiac etiology; Chronic renal failure requiring hemodialysis; Cardiac arrest with non-shockable rhythm; Cardiac arrest with unknown no flow duration; Total duration of cardiac arrest (no flow plus low flow) > 45 minutes; Known hypersensitivity to levosimendan or placebo, or one of its excipients; Immediate or anticipated (within 6 hours) indication of Extra Corporel Life Support; Use of VA-ECMO or IMPELLA or LVAD; Cardiotoxic poisoning; Septic cardiomyopathy; No flow time higher > 3 minutes; Cerebral deficit with fixed dilated pupils; Patient moribund on the day of enrollment; Irreversible neurological pathology; 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).