Spanish Randomized Clinical Trial to Compare Levosimendan Versus Placebo in Postoperative Cardiac Surgery (SPARTANS)
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Low cardiac output Syndrome (LCOS) is a complication that appears in approximately 20% of
cardiac surgeries with extracorporeal circulation. LCOS is associated with increased
mortality, delayed recovery and prolonged hospital stay. The Spanish Randomized Clinical
Trial on Levosimendan (brand name: Sindax) (SPARTANS) aims to demonstrate the effectiveness
of the preoperative use of Levosimendan in reducing LCOS in patients with poor left ventricle
ejection fraction (LVEF) undergoing elective cardiac surgery.
SPARTANS study is a multicenter, randomized triple-blind, placebo-controlled trial. 300
patients with LVEF ≤ 35%, undergoing elective cardiac surgery will be recruited from 9
Spanish hospitals and randomized into two groups: Preoperative administration of levosimendan
or placebo for 24 hours. The study drug will be started as a continuous infusion (0.1
µg/kg/min) at least 8 hours before surgery to complete 24h duration.
The primary endpoint will be 30-day LCOS. It will be evaluated using any of the following
criteria:
1) postoperated cardiac index ≤2.0 L / min / m2, 2) a need to implant a intra-aortic balloon
pump/ left ventricular assist device, 3) a vasoactive inotropic scale (VIS) > 5.5.
The secondary end-point will be composite event rate at one year including any of the
following events: death from any cause, need for renal replacement therapy or dialysis and
LCOS.
The sample size is based on the assumption that levosimendan reduces LCOS by 50% being
necessary a sample size of 300 patients to carry out the study.
The Research Team of each hospital, will carry out the clinical follow-up by telephone or
clinical interview of the patient according to the time intervals: 30 days and 1 year. We
estimate that the total sample size of 300 patients will be reached in 2-2.5 years.
In conclusion, the effectiveness of levosimendan has not yet been reported with a good
evidence in cardiac surgery. The purpose of the "Spanish Randomized Clinical Trial on Sindax"
(SPARTANS) trial is to evaluate the beneficial effect of preoperative use of levosimendan
compared with placebo to reduce perioperative LCOS in patients undergoing cardiac surgery
with poor LVEF ≤ 35%.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
María de los Ángeles Tena Pajuelo
Collaborators:
Canary Foundation CRO TRIDE Asesores SL Dr Negrin Hospital Farmacy Dr Negrin Hospital Statistician Orion Corporation, Orion Pharma QBE Europe SA/NV