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

Recruiting Phase 3 Interventional Study
Cardiogenic Shock
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
610 (estimated)
Sponsor
Pr Bruno LEVY · Other
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About This Trial
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 car…
Trial Locations
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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…
Contacts

Bruno LEVY, Pr

+33 3 83 15 40 84

b.levy@chru-nancy.fr

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