A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design

Alberto Zangrillo, Gabriele Alvaro, Antonio Pisano, Fabio Guarracino, Rosetta Lobreglio, Nikola Bradic, Rosalba Lembo, Stefano Gianni, Maria Grazia Calabrò, Valery Likhvantsev, Evgeny Grigoryev, Giuseppe Buscaglia, Giovanni Pala, Elisabetta Auci, Bruno Amantea, Fabrizio Monaco, Giovanni De Vuono, Antonio Corcione, Nicola Galdieri, Claudia CarielloTiziana Bove, Evgeny Fominskiy, Stefano Auriemma, Massimo Baiocchi, Alessandro Bianchi, Mario Frontini, Gianluca Paternoster, Fabio Sangalli, Chew Yin Wang, Maria Chiara Zucchetti, Giuseppe Biondi-Zoccai, Marco Gemma, Michael J. Lipinski, Vladimir V. Lomivorotov, Giovanni Landoni

Research output: Contribution to journalArticle

Abstract

Objective Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes. Design Double-blind, placebo-controlled, multicenter randomized trial. Setting Tertiary care hospitals. Interventions Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours. Measurements and main results The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction. Conclusions This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.

Original languageEnglish
Pages (from-to)66-73
Number of pages8
JournalAmerican Heart Journal
Volume177
DOIs
Publication statusPublished - Jul 1 2016

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ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Zangrillo, A., Alvaro, G., Pisano, A., Guarracino, F., Lobreglio, R., Bradic, N., Lembo, R., Gianni, S., Calabrò, M. G., Likhvantsev, V., Grigoryev, E., Buscaglia, G., Pala, G., Auci, E., Amantea, B., Monaco, F., De Vuono, G., Corcione, A., Galdieri, N., ... Landoni, G. (2016). A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design. American Heart Journal, 177, 66-73. https://doi.org/10.1016/j.ahj.2016.03.021