In short
This article provides information about ongoing clinical trials for patients with cardiac valve disease. Currently, there are 2 trials actively recruiting or planned, focusing on anesthesia management during cardiac surgery and post-operative blood clot prevention following valve replacement. These studies are being conducted in Austria and France.
Clinical trial locations
- Austria
- France
Study on Propofol and Remifentanil for Patients with Heart Disease Undergoing Cardiac Anesthesia with Cardiopulmonary Bypass
This clinical trial, taking place in Austria, focuses on improving anesthesia care during heart surgery that requires a heart-lung machine, also called cardiopulmonary bypass. The study examines two important anesthesia medications: propofol and remifentanil.
Who can participate:
- Adults between 18 and 90 years old
- Patients scheduled for planned (non-emergency) heart surgery
- Surgery must involve the use of cardiopulmonary bypass
- Must be able to provide informed consent
Who cannot participate:
- People with valvular heart disease (where heart valves are not working properly)
- People with coronary heart disease (narrowed or blocked blood vessels supplying the heart)
- People with aortic disorders (problems with the main artery carrying blood from the heart)
What the trial studies:
The main goal is to test whether a specific prediction model, called the Eleveld Pharmacokinetic Model, can accurately predict how propofol and remifentanil behave in the body during surgery. Propofol helps patients fall asleep and stay unconscious during the procedure, while remifentanil is a strong painkiller that keeps patients comfortable.
During surgery, researchers will measure the actual levels of these medications in the blood and compare them to what the model predicted. They want to ensure the predictions are accurate within a range of 20% above or below the actual values. The study will also monitor the depth of anesthesia using various measurements to ensure patient safety throughout the procedure.
Investigational drugs:
Propofol is a medication that helps patients relax and fall asleep before and during surgery. It is given directly into the bloodstream through an intravenous line. This trial is studying how well its concentration in the body can be predicted during cardiac surgery.
Remifentanil is a strong painkiller used during surgery to manage pain and keep patients comfortable. Like propofol, it is given intravenously and works quickly. The trial examines how accurately the levels of remifentanil can be predicted using the pharmacokinetic model.
Study Comparing Apixaban and Carbasalate Calcium for Patients with Aortic Valve Replacement Due to Heart Disease
This clinical trial, conducted in France, focuses on patients who have recently had their aortic valve replaced with a bioprosthetic valve (a valve made from animal tissue). The study compares two different medications to prevent complications after surgery.
Who can participate:
- Adults aged 18 years or older
- Patients who had a bioprosthetic valve placed in the aortic position at least 7 days ago, before leaving the hospital
- Patients who do not need ongoing blood thinner treatment for other conditions like irregular heartbeat or blood clots
- Must be affiliated with social security
- Must be able to provide informed written consent
Who cannot participate:
- Patients who have not had a recent surgical replacement of the aortic valve with a bioprosthetic valve
- Patients who are not taking blood clot prevention medication
- Patients who are not at risk for complications like heart attack, stroke, or blood clots
- Patients who have not experienced valve thrombosis (blood clot formation on the heart valve)
What the trial studies:
The study compares apixaban with aspirin to see which medication is more effective at preventing serious complications after valve replacement surgery. These complications include death, heart attacks, strokes, blood clots in the lungs or veins, and problems with the new heart valve.
Participants will be randomly assigned to receive either apixaban or aspirin for approximately 105 days (about 3.5 months). Throughout this period, their health will be closely monitored to assess the effectiveness and safety of each treatment. The study pays special attention to any bleeding side effects, as both medications affect blood clotting.
Investigational drugs:
Apixaban is an anticoagulant medication that prevents blood clots by making it harder for blood to form clots. This is particularly important for patients who have had heart valve replacement surgery, as they face a higher risk of developing clots. The study aims to determine if apixaban is more effective than aspirin at preventing serious complications like heart attacks, strokes, or blood clots in the lungs or legs.
Aspirin (carbasalate calcium) is commonly known for pain relief, but it also helps prevent blood clots. In this trial, aspirin serves as the comparison medication to see if it is as effective as apixaban in preventing blood clots and related complications in patients who have had heart valve replacement surgery.
Summary
Currently, there are 2 ongoing clinical trials for cardiac valve disease, with research taking place in Austria and France. These trials address different aspects of patient care: one focuses on optimizing anesthesia during cardiac surgery, while the other examines the best medication to prevent blood clots after valve replacement.
The Austrian trial is particularly focused on improving the safety and effectiveness of anesthesia by testing a predictive model for medication levels during surgery. The French trial addresses an important question for patients who have undergone valve replacement: which medication better prevents serious complications in the months following surgery.
Both trials reflect current priorities in cardiac valve disease care—ensuring safe surgical procedures and optimizing recovery outcomes. Patients interested in participating should discuss these options with their healthcare providers to determine if they meet the eligibility criteria.
