Ongoing Clinical Trials Related to Coronary Artery Bypass
Currently, there is 1 ongoing clinical trial investigating treatments for patients undergoing heart valve surgery related to coronary artery bypass procedures. This trial is being conducted in France and focuses on preventing complications after tricuspid valve surgery in patients with right ventricular dysfunction.
Clinical trial locations
- France
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.
Summary
Currently, there is only one clinical trial available for patients undergoing heart valve surgery related to coronary artery bypass procedures. This trial is being conducted exclusively in France and focuses on the use of levosimendan to prevent complications in patients with right ventricular dysfunction undergoing tricuspid valve surgery. The study specifically targets patients with moderate to severe tricuspid regurgitation and aims to reduce the risk of low cardiac output syndrome following surgery. Patients interested in participating should be between 18 and 85 years of age, have no severe liver or kidney dysfunction, and meet other specific health requirements. The trial represents an important step in understanding how preventive medication can improve outcomes for patients undergoing this type of heart surgery.
