Early administration of LEvosimendan in Patients witH decompensAted chroNic hearT failure (ELEPHANT) study. Rationale and protocol of the study

Abstract

Dobutamine and levosimendan are both indicated for inotropic support in acute decompensated heart failure (HF).The study aimed to assess the impact of early administration of levosimendan (first iv therapeutic approach) versus dobutamine (first iv therapeutic approach) on in-hospital treatment expenses and clinical outcomes in patients with decompensated chronic HF.The ELEPHANT study was designed as a phase III, multicentre, randomized 1:1, double-blind, active-controlled trial that will include patients admitted to the hospital due to HF decompensation. Co-primary endpoints were defined as total in-hospital expenses/survivor and duration of hospitalization/survivor. Secondary efficacy endpoints: on the last day of hospitalization: occurrence of treatment side effects, body weight change during hospitalization, BNP change during hospitalization, in-hospital mortality, additional levosimendan administration due to the ineffectiveness of the initial treatment. Patients will be randomized 1:1 to the active group receiving continuous infusion 24 h of levosimendan 0.1 μg/kg/min or to the control group receiving continuous infusion 24 h of dobutamine 3 μg/kg/min.After the enrolment of 20 patients, results analysis will be performed (pilot phase -single centre). Based on this analysis conducted according to the intention-to-treat principle, the final population size will be defined. The multicentre phase of the study will be initiated after the pilot phase.