Ongoing Clinical Trials for Right Ventricular Dysfunction
Currently, there is 1 ongoing clinical trial investigating treatment options for patients with right ventricular dysfunction who require tricuspid valve surgery. This trial is examining whether a medication called levosimendan, given before surgery, can help prevent complications after heart valve operations.
Clinical trial locations
- France
Study of Levosimendan Before Tricuspid Valve Surgery in Patients with Right Ventricular Dysfunction
This clinical trial is designed for patients who need surgery to repair or replace their tricuspid valve, which is one of the four heart valves. When this valve doesn’t close properly, it causes a condition called tricuspid regurgitation, where blood flows backward instead of moving forward through the heart. This trial is testing whether giving a medication called levosimendan before surgery can help prevent serious complications after the operation.
Who can participate in this trial?
To be eligible for this study, participants must meet several criteria:
- Be between 18 and 85 years of age
- Be enrolled in the French healthcare system and able to provide written consent
- Be scheduled for heart surgery to correct moderate to severe tricuspid valve leakage
- Have evidence of severe valve leakage, such as a leaking area larger than 20 square millimeters, a blood flow width greater than 7 millimeters, or abnormal blood flow patterns in the liver veins
Who cannot participate?
Several conditions exclude patients from this trial, including:
- Severe liver dysfunction or kidney failure requiring dialysis
- Known allergies to levosimendan or similar medications
- Pregnancy or breastfeeding
- Unstable heart condition requiring emergency surgery
- Severe low blood pressure (systolic blood pressure below 90 mmHg)
- Uncontrolled severe heart rhythm disorders
- Severe lung disease requiring oxygen therapy or significant blood clotting disorders
- Active infection or fever
What is the focus of this trial?
The main goal of this research is to determine whether levosimendan can help prevent a serious complication called low cardiac output syndrome. This condition occurs when the heart cannot pump enough blood to meet the body’s needs after surgery. Patients in the trial will receive either levosimendan or placebo (a substance with no active medication, in this case a 5% glucose solution) through an intravenous infusion before their tricuspid valve surgery.
After the operation, patients will be carefully monitored for 90 days. During this time, doctors will watch for signs of heart-related complications, including whether patients need additional medications to support heart function, devices to help the heart pump blood more effectively, or special treatments to support kidney function.
What medication is being tested?
The investigational drug in this trial is levosimendan, which is marketed under the brand name ZIMINO. This medication helps improve heart function in two important ways: it makes the heart muscle contract more strongly and helps blood vessels relax. Levosimendan works by increasing the sensitivity of heart muscle cells to calcium, which enhances the heart’s pumping ability without significantly increasing the amount of oxygen the heart needs. This makes it particularly useful for patients whose right side of the heart isn’t working as well as it should, especially before undergoing tricuspid valve surgery.
Summary
Currently, there is only one clinical trial actively recruiting patients with right ventricular dysfunction. This trial is being conducted in France and focuses specifically on patients requiring tricuspid valve surgery. The study examines whether pre-surgical administration of levosimendan can reduce the risk of low cardiac output syndrome and other complications following heart valve surgery. This focused approach reflects the specific challenge of managing right ventricular dysfunction in the context of tricuspid valve disease, a condition that can significantly impact heart function and patient outcomes.