Cardiac valve disease – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 12 Jun 2026 11:21:42 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Cardiac valve disease – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 A Study of Intravenous Lidocaine to Reduce Inflammation in Patients Undergoing Heart Valve or Coronary Artery Bypass Surgery with Heart-Lung Machine https://clinicaltrials.eu/trial/a-study-of-intravenous-lidocaine-to-reduce-inflammation-in-patients-undergoing-heart-valve-or-coronary-artery-bypass-surgery-with-heart-lung-machine/ Thu, 30 Apr 2026 13:08:33 +0000 https://clinicaltrials.eu/trial/a-study-of-intravenous-lidocaine-to-reduce-inflammation-in-patients-undergoing-heart-valve-or-coronary-artery-bypass-surgery-with-heart-lung-machine/ This study involves patients who are having planned heart surgery to repair or replace heart valves or to bypass blocked coronary arteries. During these operations, a heart-lung machine, also called cardiopulmonary bypass, is used to temporarily take over the work of the heart and lungs. This machine can trigger a body-wide inflammatory response, which is the body’s reaction to injury or stress, and this response can sometimes lead to problems after surgery such as kidney injury, infection, organ dysfunction, bleeding, low blood pressure, breathing difficulties, and brain-related issues. The study will test whether giving lidocaine through a vein during and after surgery can reduce this inflammatory response. Lidocaine is a medication commonly used as a local painkiller, but it may also have effects that calm down inflammation in the body. Patients will receive either lidocaine or placebo, which is a solution that looks the same but contains only sodium chloride, a salt water solution.

The purpose of the study is to find out whether lidocaine given through a vein can lower the levels of a substance called interleukin-6 in the blood six hours after surgery ends. Interleukin-6 is a marker of inflammation in the body, and high levels of it are associated with the inflammatory response caused by the heart-lung machine. The study will also measure other markers of inflammation and heart stress, including C-reactive protein, high-sensitivity Troponin T, and TNF-α, at different times before, during, and after surgery. Additionally, the study will look at whether patients who receive lidocaine have fewer complications after surgery, spend less time in the intensive care unit, have better survival rates one month after surgery, and experience less pain in the days following the operation.

Patients in the study will be randomly assigned to receive either lidocaine or placebo during their surgery and for a period afterward. Neither the patients nor the doctors will know which treatment is being given, which helps ensure fair and accurate results. Blood samples will be taken at specific times to measure the inflammation markers, and information about any complications, length of stay in the intensive care unit, heart rhythm problems after the heart is restarted, pain levels, and need for pain medication will be collected. The study is expected to begin enrolling patients in October 2025 and continue until April 2027.

]]> Study Comparing Apixaban and Carbasalate Calcium for Patients with Aortic Valve Replacement Due to Heart Disease https://clinicaltrials.eu/trial/study-comparing-apixaban-and-carbasalate-calcium-for-patients-with-aortic-valve-replacement-due-to-heart-disease/ Wed, 29 Apr 2026 15:04:58 +0000 https://clinicaltrials.eu/trial/study-comparing-apixaban-and-carbasalate-calcium-for-patients-with-aortic-valve-replacement-due-to-heart-disease/ The study focuses on patients who have undergone surgery to replace their aortic valve with a bioprosthetic valve due to valvular heart disease. The purpose of the study is to compare two treatments to see which is more effective in preventing complications. The treatments being compared are apixaban, a medication that helps prevent blood clots, and aspirin, which is commonly used to reduce the risk of heart attacks and strokes.

Participants in the study will be randomly assigned to receive either apixaban or aspirin. The study will last for about 120 days, during which time the health of the participants will be closely monitored. The main goal is to see if apixaban is better than aspirin at preventing serious health problems such as death, heart attacks, strokes, blood clots in the lungs or veins, and issues with the new heart valve.

Throughout the study, the safety of the participants will be a priority, and any side effects, especially bleeding, will be carefully tracked. The study aims to provide valuable information that could improve the care of patients with bioprosthetic aortic valves in the future.

]]> Study on Propofol and Remifentanil for Patients with Heart Disease Undergoing Cardiac Anesthesia with Cardiopulmonary Bypass https://clinicaltrials.eu/trial/study-on-propofol-and-remifentanil-for-patients-with-heart-disease-undergoing-cardiac-anesthesia-with-cardiopulmonary-bypass/ Wed, 29 Apr 2026 14:29:50 +0000 https://clinicaltrials.eu/trial/study-on-propofol-and-remifentanil-for-patients-with-heart-disease-undergoing-cardiac-anesthesia-with-cardiopulmonary-bypass/ This clinical trial is focused on studying the effects of two medications, Propofol and Remifentanil, during heart surgeries that involve the use of a heart-lung machine, known as cardiopulmonary bypass. The diseases being studied include valvular heart disease, coronary heart disease, and aortic disorders. The purpose of the study is to evaluate a model that predicts how these medications behave in the body during surgery. This model is called the Eleveld Pharmacokinetic Model.

Participants in the study will receive either Propofol or Remifentanil through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will compare the actual levels of these medications in the blood with the levels predicted by the model. This will help determine if the model can accurately predict how the medications work during surgery. The study will also involve a placebo group to compare results.

The trial will last for a short period, focusing on the time during and immediately after the surgery. The researchers will collect data on the concentration of the medications in the blood and compare it to the predictions made by the model. This information will help improve the understanding of how these medications can be used safely and effectively during heart surgeries. The study aims to ensure that the model’s predictions are within an acceptable range, which will help in providing better anesthesia care for patients undergoing these types of surgeries.

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