Study on Preventing Atrial Fibrillation After Heart Surgery Using Landiolol Hydrochloride in Patients with Normal Heart Function
This clinical trial is investigating whether a medication called landiolol hydrochloride can help prevent atrial fibrillation in patients having heart surgery. Atrial fibrillation is an irregular heartbeat that commonly occurs after cardiac procedures and can cause complications if not managed properly.
Who can participate:
The study is looking for patients who meet specific criteria. Participants must be at least 18 years old and currently have a normal heartbeat pattern called sinus rhythm. They should already be taking oral beta-blocker medication as part of their regular treatment. Patients must be scheduled for planned heart surgery that uses a heart-lung machine, including procedures such as valve surgery, coronary artery bypass grafting, or combinations of these procedures. The surgery must be elective, meaning it is planned in advance rather than an emergency. All participants must provide written informed consent, showing they understand the study and agree to take part.
Who cannot participate:
According to the trial information, patients who are currently taking beta-blockers, have normal heart pumping function, or have a normal heartbeat pattern cannot participate. These exclusion criteria may reflect specific study design considerations.
What the trial involves:
The main goal of this study is to determine whether landiolol hydrochloride is effective in preventing atrial fibrillation after heart surgery. Landiolol hydrochloride is a type of beta-blocker medication that works by slowing down the heart rate and helping maintain a normal rhythm. During the trial, participants will receive either landiolol hydrochloride or a placebo through an infusion directly into the bloodstream during and after their surgery.
After surgery, patients will be closely monitored for 72 hours to check for irregular heartbeats and other complications. Medical staff will regularly measure blood pressure and heart rate at specific intervals: when admitted to the intensive care unit and at 24, 48, and 72 hours after surgery. Observation continues for up to seven days to ensure stability and monitor for any further irregular heartbeats. If irregular heartbeats do occur, standard care will be provided.
The investigational drug:
Landiolol hydrochloride is the medication being tested in this trial. It is administered through an intravenous infusion in a hospital setting. As a beta-blocker, it works by blocking specific receptors in the heart, which leads to a decreased heart rate and helps maintain normal heart rhythm. The study will compare its effectiveness against a placebo to determine whether it provides a safe and effective option for preventing atrial fibrillation in patients undergoing heart surgery.
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