Informations générales (source: ClinicalTrials.gov)
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 (LevoHeartShock)
Interventional
Phase 3
Central Hospital, Nancy, France (Voir sur ClinicalTrials)
juillet 2023
janvier 2028
27 août 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL PRIVE DE MARNE LA VALLEE | Pascal LIM, MD-PhD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHR Metz-Thionville, Mercy Hospital - 57245 - Ars-Laquenexy - Moselle - France | Guillaume Louis, MD | Contact (sur clinicalTrials) | |||
| CHRU Nancy - Vandoeuvre les Nancy - France | Bruno Lévy, Prof | Contact (sur clinicalTrials) | |||
| CHRU Strasbourg -Nouvel Hôpital Civil - 67091 - Strasbourg - Bas-Rhin - France | Ferhat MEZIANI, MD-PhD | Contact (sur clinicalTrials) | |||
| CHU Besançon Jean Minjoz Hospital - 25000 - Besançon - Doubs - France | Hadrien WINISZEWSKI, MD | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Hopital haut-leveque - 33600 - Bordeaux - Gironde - France | Edouard Gerbaud, MD | Contact (sur clinicalTrials) | |||
| CHU Caen - 14000 - Caen - Calvados - France | Katrien Blanchart, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble, Michallon Hospital - 38043 - La Tronche - Isère - France | Joanna Bougnaud, MD | Contact (sur clinicalTrials) | |||
| CHU Limoges, Dupuytren Hospital - 87000 - Limoges - Haute-Vienne - France | Philippe Vignon, MD | Contact (sur clinicalTrials) | |||
| CHU Montpellier, site Lapeyronie - 34090 - Montpellier - Hérault - France | Kada Klouche, MD | Contact (sur clinicalTrials) | |||
| CHU Nîmes, Carémeau Hospital - 30029 - Nîmes - Gard - France | Benoît Lattuca, MD | Contact (sur clinicalTrials) | |||
| CHU Rennes, Pontchaillou Hospital - 35000 - Rennes - Ille Et Vilaine - France | Abdelkader BAKHTI, MD | Contact (sur clinicalTrials) | |||
| CHU Rouen, Charles Nicolle Hospital - 76000 - Rouen - Seine Maritime - France | Fabienne Tamion, MD | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - Louis Pradel Hospital - 69500 - Bron - Rhône - France | Eric Bonnefoy, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM CHU la Timone - 13385 - Marseille - France | Florent ARREGLE, MD | Contact (sur clinicalTrials) | |||
| AP-HM, la Timone Hospital, Marseille - 13005 - Marseille - Bouches Du Rhône - France | Marc Gainnier, MD | Contact (sur clinicalTrials) | |||
| AP-HM, Nord Hospital, Marseille - 13015 - Marseille - Bouches Du Rhône - France | Laurent Bonello, MD | Contact (sur clinicalTrials) | |||
| APHP- HEGP Paris - 75015 - Paris - France | Nadia Aissaoui Balanant, MD | Contact (sur clinicalTrials) | |||
| APHP, La Pitié Salpêtrière (medical intensive care unit) - 75013 - Paris - France | Alain Combes, MD | Contact (sur clinicalTrials) | |||
| APHP, Lariboisière Hospital (intensive care unit and toxicology) - 75010 - Paris - France | Bruno Megarbane, MD | Contact (sur clinicalTrials) | |||
| CH Henri Duffaut, Avignon - 84000 - Avignon - Vaucluse - France | Stéphane Andrieu, MD | Contact (sur clinicalTrials) | |||
| CHRU Lille, Cœur Poumon Institute - 59000 - Lille - Nord - France | Gilles LEMESLE, MD-PhD | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Bordeaux - France | Alexandre OUTARRA, MD-PhD | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - 31059 - Toulouse - Haute-Garonne - France | Clément Delmas, MD | Contact (sur clinicalTrials) | |||
| CHU Dijon - 21000 - Dijon - Côte d'Or - France | Jean-Pierre Quenot, MD-PhD | Contact (sur clinicalTrials) | |||
| Chu Dijon - Dijon - France | Pierre Grégoire GUINOT, MD-PhD | Contact (sur clinicalTrials) | |||
| CHU Grenoble -USIC - 38700 - La Tronche - France | Nicolas PILIERO, MD | Contact (sur clinicalTrials) | |||
| CHU Montpellier -hôpital Arnaud de Villeneuve - 34295 - Montpellier - France | Philippe GAUDARD, MD-PhD | Contact (sur clinicalTrials) | |||
| CHU Montpellier, Arnaud de Villeneuve Hospital - 34090 - Montpellier - Hérault - France | François Roubille, MD | Contact (sur clinicalTrials) | |||
| CHU Nantes - 44000 - Nantes - Loire-Atlantique - France | Julien Plessis, MD | Contact (sur clinicalTrials) | |||
| Chu Rouen - Rouen - France | Emmanuel BESNIER, MD-PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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 and at dose ≥ 5 microgram/kg/min at inclusion.
- Tissue hypoperfusion: at least 1 sign (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);
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 and at dose ≥ 5 microgram/kg/min at inclusion.
- Tissue hypoperfusion: at least 1 sign (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);
- 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;
- Cardiogenic choc post cardiac surgery under cardiopulmonary bypass (CPBP) weaned for
less or equal of 6 hours.
- 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)