NCT04179604 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Landoni G, Mizzi A, Biondi-Zoccai G, Bruno G, Bignami E, Corno L, Zambon M, Gerli C, Zangrillo A
Reducing mortality in cardiac surgery with levosimendan: a meta-analysis of randomized controlled trials. J Cardiothorac Vasc Anesth. 2010 Feb;24(1):51-7. do
Levin R, Degrange M, Del Mazo C, Tanus E, Porcile R
Preoperative levosimendan decreases mortality and the development of low cardiac output in high-risk patients with severe left ventricular dysfunction undergoing coronary artery bypass grafting with car
Niu ZZ, Wu SM, Sun WY, Hou WM, Chi YF
Perioperative levosimendan therapy is associated with a lower incidence of acute kidney injury after cardiac surgery: a meta-analysis. J Cardiovasc Pharmacol. 2014 Feb;63(2):107-12. doi: 10.1097/FJC.0000000000000028.
Tena MÁ, Urso S, González JM, Santana L, Sadaba R, Juarez P, González L, Portela F
Levosimendan versus placebo in cardiac surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2018 Nov 1;27(5):677-685. doi: 10.1093/icvts/ivy133

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)

Details for clinical trial NCT04179604

Clinical trial NCT04179604 - References