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Compares treatment options for Cardiogenic Shock
Official 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
ClinicalTrials.gov ID: NCT04020263
What this study is testing
What is Levosimendan 2.5 MG/ML Injectable Solution?
Levosimendan 2.5 MG/ML Injectable Solution is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cardiogenic shock.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Tissue hypoperfusion: at least 1 sign within 24h prior to inclusion (lactate ≥ 2 mmol/l; mottling, capillary refeel time \> 3 seconds, oliguria...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, Bas-Rhin, France
- Marseille, Bouches du Rhône, France
- Caen, Calvados, France
- Dijon, Côte d'Or, France
- Besançon, Doubs, France
- Nîmes, Gard, France
- Bordeaux, Gironde, France
- Toulouse, Haute-Garonne, France
- Limoges, Haute-Vienne, France
- Montpellier, Hérault, France
- Rennes, Ille et Vilaine, France
- La Tronche, Isère, France
- Nantes, Loire-Atlantique, France
- Ars-Laquenexy, Moselle, France
- Lille, Nord, France
- Paris, Paris, France
- Bron, Rhône, France
- Créteil, Val de Marne, France
- Avignon, Vaucluse, France
- Bordeaux, France
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, Bas-Rhin, France; Marseille, Bouches du Rhône, France; Caen, Calvados, France; Dijon, Côte d'Or, France; Besançon, Doubs, France; Nîmes, Gard, France and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.