US-based specialty pharmaceutical firm Tenax Therapeutics has started patient enrolment in the LEVO-CTS Phase III clinical trial designed to evaluate the benefits of levosimendan in cardiac surgery patients at risk of developing low cardiac output syndrome (LCOS).
The multi-centre, double blind, randomised, placebo-controlled LEVO-CTS trial is evaluating the hypothesis that levosimendan reduces morbidity and mortality in cardiac surgery patients at risk for developing LCOS.
Tenax, formerly known as Oxygen Biotherapeutics, has already secured fast track designation from the US Food and Drug Administration (FDA) for levosimendan in this LCOS indication.
The FDA has also agreed to the Phase III protocol design under special protocol assessment (SPA) with guidance that this single successful trial will be sufficient to support approval.
Tenax Therapeutics CEO John Kelley said: "We are pleased to begin this important Phase III study, which has been designed in consultation with leading cardiovascular experts and investigators to provide a clear answer on the potential of levosimendan to prevent complications after high-risk cardiac surgery.
"We look forward to working with our colleagues at Duke Clinical Research Institute and the other cardiac surgery centres and hospitals involved in the trial, as we continue to activate many additional clinical sites in the months ahead."
The trial is being led by Duke Clinical Research Institute (DCRI) and will be carried out at around 50 major cardiac surgery centres in North America.
Around 760 patients undergoing coronary artery bypass graft surgery or mitral valve surgery that are at risk for developing LCOS will be enrolled in the trial.
DCRI director of Cardiovascular Research and lead investigator John Alexander said: "The LEVO-CTS trial design will test levosimendan in the prevention of LCOS in high-risk patients undergoing cardiac surgery, an area of high unmet medical need and one where several smaller published clinical trials have suggested potential benefit.
"We are pleased to be getting started with enrolment and are projected to have results in early 2016."