Coronary artery bypass Trials in Disease

Study of Levosimendan Before Tricuspid Valve Surgery in Patients with Right Ventricular Dysfunction

This trial focuses on patients who need surgery for tricuspid regurgitation, a heart condition where the tricuspid valve doesn't close properly, causing blood to flow backward. The study examines whether giving a medication called levosimendan before surgery can help prevent a serious complication known as low cardiac output syndrome, which occurs when the heart cannot pump enough blood to meet the body's needs after surgery.

Main inclusion criteria:

• Must be between 18 and 85 years of age
• Must be scheduled for heart surgery to correct moderate to severe tricuspid valve leakage
• Must have at least one sign of severe tricuspid valve leakage, such as a leaking area larger than 20 square millimeters, a width of the leaking blood flow greater than 7 millimeters, or abnormal blood flow pattern in the liver veins
• Must be enrolled in the French healthcare system
• Must provide written informed consent to participate

Main exclusion criteria:

• Severe liver dysfunction or severe kidney failure requiring dialysis
• Known allergic reactions to levosimendan or similar medications
• Current pregnancy or breastfeeding
• Unstable heart condition requiring emergency surgery
• Severe low blood pressure (systolic blood pressure below 90 mmHg)
• Severe heart rhythm disorders that are not controlled by medication
• Active infection or fever
• Severe lung disease requiring oxygen therapy
• Significant blood clotting disorders that increase risk of bleeding during surgery

Focus and goal of the trial:

The study aims to determine whether administering levosimendan before tricuspid valve surgery can prevent low cardiac output syndrome and other heart-related complications. Patients will receive either levosimendan or placebo through an intravenous infusion before their surgery. After the operation, participants will be monitored for 90 days to check for signs of complications, including the need for additional medications to support heart function, the use of devices to help the heart pump blood, or the need for special treatments to support kidney function. The medical team will closely observe heart function, blood pressure, vital signs, kidney function, and overall recovery progress throughout the study period.

Investigational drug:

The trial is testing levosimendan, a medication that helps improve heart function by making the heart muscle contract more strongly and helping blood vessels relax. It works by increasing the sensitivity of heart muscle cells to calcium, thereby enhancing the heart's ability to pump blood without significantly increasing oxygen consumption. This medication is particularly useful for patients whose right side of the heart isn't working as well as it should, and it is given before heart surgery to help prevent complications related to poor heart function.