Study on Preventing Atrial Fibrillation After Heart Surgery Using Landiolol Hydrochloride in Patients with Normal Heart Function

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What is this study about?

This clinical trial is focused on studying the prevention of atrial fibrillation, a common heart rhythm disorder, in patients who are undergoing heart surgery. The study will use a medication called landiolol hydrochloride, which is a type of drug known as a beta-blocker. Beta-blockers are often used to manage heart conditions by slowing down the heart rate and reducing blood pressure. In this study, landiolol hydrochloride will be compared to a placebo to see how effective it is in preventing atrial fibrillation after surgery.

The main goal of the study is to see if landiolol hydrochloride can help prevent atrial fibrillation in patients who are having planned heart surgeries that involve the use of a heart-lung machine. These surgeries may include procedures like valve surgery or coronary artery bypass grafting. The study will monitor patients for the occurrence of atrial fibrillation and other outcomes during the first 72 hours after surgery, as well as over the first week.

Participants in the study will receive either landiolol hydrochloride or a placebo through an infusion, which is a way of delivering medication directly into the bloodstream. The study will help determine if landiolol hydrochloride is a safe and effective option for preventing atrial fibrillation in patients undergoing heart surgery. The results could provide valuable information for improving care and outcomes for these patients.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, heart rhythm, and planned cardiac surgery.

Written consent is required to participate.

2 pre-surgery preparation

Before surgery, the patient is prepared for the procedure, which includes ensuring they are in sinus rhythm and have a normal heart function.

The patient continues their regular beta-blocker medication.

3 surgery and initial treatment

During the cardiac surgery, which is performed using a heart-lung machine, the patient receives an infusion of landiolol hydrochloride to prevent irregular heartbeats.

The infusion is administered as a solution through a drip.

4 post-surgery monitoring

After surgery, the patient is monitored for 72 hours to check for any irregular heartbeats or other complications.

Blood pressure and heart rate are measured regularly, especially upon admission to the intensive care unit and at 24, 48, and 72 hours post-surgery.

5 extended observation

The patient continues to be observed for up to seven days after surgery to ensure stability and to monitor for any further irregular heartbeats.

Standard care for irregular heartbeats is initiated if necessary.

Who Can Join the Study?

Patients must be 18 years old or older.
Patients must provide written informed consent, which means they agree to participate after understanding the study.
Patients must have a sinus rhythm, which is a normal heartbeat pattern.
Patients must be taking an oral beta-blocker as part of their regular medication. Beta-blockers are medicines that help manage heart conditions.
Patients must be scheduled for one of the following cardiac surgeries using a heart-lung machine, known as cardiopulmonary bypass (CPB):
- Single valve surgery
- Single or multiple coronary artery bypass grafting (CABG) procedures, which help improve blood flow to the heart
- Single valve surgery combined with one or more CABG procedures
- Multiple valve surgery, with or without CABG
- Single or multiple valve surgery combined with an ascending aorta procedure, with or without CABG
- Re-surgery of the aortic valve, mitral valve, aortic arch, or ascending aorta, with or without CABG
The cardiac surgery must be elective, meaning it is planned in advance and not an emergency.

Who Cannot Join the Study?

If you are currently taking beta-blockers, which are medications that help manage heart conditions, you cannot participate.
If you have a normal left ventricular ejection fraction, meaning your heart is pumping blood normally, you cannot participate.
If you have a sinus rhythm, which is a normal heartbeat pattern, you cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	21.10.2021

Trial locations

Investigated drugs:

Landiolol Hydrochloride

Landiolol is a medication being studied for its ability to prevent atrial fibrillation, which is a type of irregular heartbeat, in patients who are having heart surgery. It is used to help maintain a normal heart rhythm after the surgery.

Investigated diseases:

Atrial Fibrillation – Atrial fibrillation is a common heart rhythm disorder where the heart’s upper chambers (atria) beat irregularly and often rapidly. This can lead to poor blood flow and may cause symptoms like palpitations, fatigue, and shortness of breath. The condition can occur sporadically or become a chronic issue. It often progresses from short, occasional episodes to longer, more persistent ones. Over time, atrial fibrillation can lead to complications such as blood clots or heart failure if not managed properly. The progression and severity can vary widely among individuals.

Trial ID:

2024-518950-17-00

Protocol code:

Version: 2.1

NCT ID:

NCT20245189

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Atrial Fibrillation After Heart Surgery Using Landiolol Hydrochloride in Patients with Normal Heart Function

What is this study about?

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