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 undergoing planned heart surgery. Atrial fibrillation is a common irregular heartbeat that can occur after heart surgery, and preventing it may improve recovery and outcomes for patients.
Who can join this trial?
To be eligible for this study, patients must meet several criteria:
- Be at least 18 years old
- Have a normal heartbeat pattern called sinus rhythm
- Be taking beta-blocker medication regularly
- Be scheduled for planned heart surgery using a heart-lung machine
- Provide written consent to participate after understanding the study details
The types of heart surgery included in this study are valve surgery, coronary artery bypass grafting (a procedure to improve blood flow to the heart), or combinations of these procedures. Some patients having repeat surgeries may also be eligible.
Who cannot join this trial?
Patients cannot participate if they have certain conditions, though the exclusion criteria appear to overlap with inclusion requirements. This suggests the trial has specific heart function requirements that distinguish eligible patients from those who are not suitable for the study.
What is the focus of this trial?
The main goal is to determine whether landiolol hydrochloride is effective and safe for preventing atrial fibrillation during the first 72 hours after heart surgery. The study will also monitor patients for up to one week after surgery.
Patients in the trial will receive either landiolol hydrochloride or a placebo through an infusion directly into the bloodstream during and after surgery. The medication is a type of beta-blocker that works by slowing down the heart rate and helping maintain a normal heart rhythm.
What happens during the trial?
The study follows a clear timeline:
- Joining the study: Eligibility is confirmed based on age, heart rhythm, and planned surgery type
- Before surgery: Patients continue their regular beta-blocker medication and are prepared for the procedure
- During surgery: The infusion of landiolol hydrochloride is given through a drip while the heart surgery is performed
- After surgery: Patients are monitored closely for 72 hours in the intensive care unit, with regular checks of blood pressure and heart rate
- Extended monitoring: Observation continues for up to seven days to watch for any irregular heartbeats or complications
About the investigational drug
Landiolol hydrochloride is given intravenously in a hospital setting. It belongs to a class of medications called beta-blockers, which work by blocking certain receptors in the heart. This action decreases heart rate and helps maintain normal heart rhythm, which is particularly useful after heart surgery when irregular heartbeats are more likely to occur.
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