A Randomized, Double-Blind Study of Landiolol to Protect the Heart During Elective Mitral Valve Repair or Replacement Surgery in Adults

What this Trial Is About

Researchers are evaluating the use of landiolol, an ultra-short acting beta-blocker, as an additional treatment during open mitral valve surgery to reduce the occurrence of postoperative low-cardiac output syndrome LCOS. Chronic mitral regurgitation is a common heart valve problem that can lead to serious complications and death if untreated. This Phase 4 randomized, controlled, double-blind trial aims to provide high-quality evidence on whether landiolol improves heart protection during surgery and reduces complications after surgery. The study compares two groups one receiving landiolol as a low-dose continuous infusion until aortic cross-clamping, followed by intravenous boluses before cross-clamping and added to the cardioplegic solution the other group receives a placebo saline solution in the same manner. The intervention occurs during the operation, with landiolol given intravenously to evaluate its effect on heart protection while the heart is stopped. The study includes 1500 patients undergoing open mitral valve repair or replacement surgery. Participants will be monitored until intensive care unit discharge, hospital discharge, and one year after surgery. Researchers will assess the occurrence of LCOS, the need for prolonged catecholamine infusion, changes in cardiac biomarkers and heart function, hospital readmissions for heart reasons, quality of life questionnaires, and mortality. The primary outcome is the reduction of LCOS until ICU discharge, about 4 days. Follow-up includes assessments up to one year post-surgery to evaluate longer-term outcomes.

Landiolol in Mitral Valve Surgery