NCT04179604: SPARTANS

Rationale and Design of a Multicenter Randomized Trial of Levosimendan to Reduce Low Cardiac Output Syndrome in Low Ejection Fraction (≤ 35%) Cardiac Surgery Patients. Spanish Randomized Clinical Trial on Levosimendan (SPARTANS Study)

Status unknown Phase 2/Phase 3 Last updated 22 July 2020

What this trial tests

Phase 2/Phase 3 trial testing Levosimendan in Cardiac Output, Low in 300 participants. Status unknown.

Timeline

17 June 2020

Primary endpoint
1 January 2022

1 December 2022

Quick facts

Lead sponsor	María de los Ángeles Tena Pajuelo
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	300
Start date	17 June 2020
Primary completion	1 January 2022
Estimated completion	1 December 2022
Sites	9 locations across Spain

Drugs / interventions tested

• Levosimendan (LEVOSIMENDAN) — full drug profile →
• Placebos — full drug profile →

Conditions studied

• Cardiac Output, Low — all drugs for Cardiac Output, Low →

Sponsor

María de los Ángeles Tena Pajuelo

Who can join

18 and older, any sex, with Cardiac Output, Low. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants with LCOS
  Time frame: up to 30 days of cardiac surgery
  LCOS will be considered if: 1\) Postoperated cardiac index ≤2.0 L / min / m2 (liters / minute / square meter)
• Number of Participants with LCOS
  Time frame: up to 30 days of cardiac surgery
  LCOS will be considered if: 2\) The need to implant an intra-aortic balloon pump
• Number of Participants with LCOS
  Time frame: up to 30 days of cardiac surgery
  LCOS will be considered if: 3\) The need to implant a left ventricular assistance device
• Number of Participants with LCOS
  Time frame: up to 30 days of cardiac surgery
  LCOS will be considered if: 4\) To have a vasoactive inotropic scale (VIS) \> 5.5 Vasoactive inotropic scale will be measured following the following formula: inotropic scale (IS) + 10 x Milrinone (μg / kg / min) + 100 x norepinephrine (μg / kg / min) + 10000 × vasopressin (U / kg / min). The inotropic scale (SI) will be calculated using the following formula: Dopamine (μg / kg / min) + Dobutami

Sponsor's own description

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%.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evidence and Current Use of Levosimendan in the Treatment of Heart Failure: Filling the Gap.
   Conti N, Gatti M, Raschi E, Diemberger I, et al · · 2021 · cited 19× · PMID 34376973 · DOI 10.2147/dddt.s295214
2. Prophylactic use of inotropic agents for the prevention of low cardiac output syndrome and mortality in adults undergoing cardiac surgery.
   Gayatri D, Tongers J, Efremov L, Mikolajczyk R, et al · · 2024 · cited 2× · PMID 39601298 · DOI 10.1002/14651858.cd013781.pub2
3. Cardiotoxicity of Chemotherapy: A Multi-OMIC Perspective.
   Ma Y, Grootaert MOJ, Sewduth RN. · · 2025 · cited 1× · PMID 39846541 · DOI 10.3390/jox15010009