Spanish Randomized Clinical Trial to Compare Levosimendan Versus Placebo in Postoperative Cardiac Surgery (SPARTANS)

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Simendan

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Written informed consent

• LVEF ≤35% detected by echocardiography carried out at least one week before surgery.

• Scheduled AVR or/and Scheduled CABG with CBP.

Exclusion Criteria:

• Previous levosimendan administration.

• Emergency operation.

• Kidney or liver trasplant or awaiting it.

• Hepatic cirrhosis Child C. In case Child B, contact coordinating center.

• Any degree of preoperative right ventricular failure.

• Preoperative creatinine > 2 mg / dl.

• Valve desease other than aortic.

• Renal failure requering dialysis (or creatinine clearance < 30ml / min).

• Hemodynamic instability (need for inotropics, unstable angina, acute myocardial infarction, intra-aortic balloon pump).

• Patients underwent previous cardiac surgery.

• Allergy or hypersensitivity to levosimendan or any of its excipients

• Severe hypotension (sistolic arterial tension < 80 mmHg or mean arterial pressure <50 mmHg ) and tachycardia ( heart rate >130 bpm).

• History of Torsades de Pointes.

• Pregnancy or breast-feeding