Centre Medico Chirurgical Ambroise Pare Hartmann
Verified site
Neuilly-Sur-Seine, France
Not yet recruiting
Landiolol hydrochloride to prevent new‑onset atrial fibrillation after heart surgery in Caucasian patients undergoing cardiopulmonary bypass
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The study focuses on patients scheduled for elective cardiac surgery that uses cardiopulmonary bypass, a machine that temporarily takes over the work of the heart and lungs during the operation. The condition of interest is new‑onset atrial fibrillation, an irregular and often rapid heartbeat that can develop after surgery. The treatment being tested is an intravenous infusion of landiolol, added to the usual oral beta blocker medication, while a placebo (salt water) is used for comparison.
The purpose is to determine whether the preventive infusion lowers the number of patients who develop atrial fibrillation within the first seven days after the operation. Participants are randomly assigned to receive either the active drug or the placebo, and the study is double‑blind, meaning neither the medical team nor the participant knows which treatment is given.
After surgery, participants remain in the intensive care unit where their heart rhythm is continuously watched with an electrocardiographic tracing and later with a 7‑day Holter monitor, a small device that records heart activity for several days. Heart rate and blood pressure are measured each hour for the first three days, and the lengths of stay in the intensive care unit and in the hospital are recorded. Safety is monitored for serious problems such as very slow heart rate, very low blood pressure, or other severe heart events.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Be 65 years old or older.
- Identify as Caucasian (a term used to describe a certain ethnic background).
- Plan to have a elective (scheduled, non‑emergency) heart operation that uses a machine called cardiopulmonary bypass to take over the work of the heart and lungs during surgery, and have a pre‑surgery measurement of left ventricular ejection fraction (a test that shows how well the main pumping chamber of the heart works) of 50% or higher.
- Be covered by a social security system or a similar health‑insurance program.
- Provide a free, informed consent that is signed (agree to take part after understanding the study).
Who cannot join the trial?
11 criteria
- You are younger than 65 years old.
- You are under legal guardianship or other court protection, or you cannot give consent because you are not free to make decisions.
- You are unable to give your own consent or you are a legally protected adult.
- You have had episodes of irregular heart rhythm called atrial fibrillation before the surgery, whether occasional (paroxysmal) or ongoing (persistent).
- You cannot take beta‑blocker medicines or you are allergic to the study drug landiolol.
- You have a serious heart rhythm problem such as complete atrioventricular block (the electrical signal between heart chambers is fully blocked) or a very slow heart rate (bradycardia) that needs a temporary external pacemaker.
- After the heart surgery you are in cardiogenic shock (the heart cannot pump enough blood) and need medicines that strengthen heart pumping, called inotropic agents, such as adrenaline or dobutamine.
- You have vasoplegic syndrome, meaning your blood pressure stays low (mean arterial pressure below 65 mmHg) even though you are receiving strong blood‑pressure medication like noradrenaline at a high dose.
- You have acute respiratory distress syndrome (severe lung injury) shown by a low oxygen measurement (a PaO2/FiO2 ratio less than 200).
- You are considered moribund (very critically ill) with a Simplified Acute Physiology Score II (SAPS II) higher than 90, indicating a high risk of death.
- You have a mental condition or language barrier that prevents you from understanding the study information.
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Investigated drugs
RAPIBLOC
is an intravenous medication that contains landiolol, a fast‑acting beta‑blocker. In this study it is given as a continuous infusion after heart surgery to see if it can lower the chance of developing new atrial fibrillation during the first week after the operation.
Oral beta‑blocker
(the usual pill form of a beta‑blocking drug) is taken by all patients before the surgery. It works by slowing the heart’s rhythm and reducing the heart’s workload. In the trial it is used as the standard background treatment, while the researchers test whether adding the landiolol infusion on top of it gives extra protection against postoperative atrial fibrillation.
What is already known about the treatment
Sodium Chloride 0.9% solution for infusion
This medication is given by intravenous (IV) infusion, where a sterile fluid is slowly dripped into a vein. It is a well‑known, widely used saline solution that has been part of medical practice for many decades. The main use is to replace fluids and electrolytes, helping keep the body’s water and salt balance normal. It belongs to the class of isotonic electrolyte solutions and works simply by adding sodium and chloride ions to the bloodstream.
Landiolol Hydrochloride (RAPIBLOC)
This drug is administered as an IV infusion, mixed into a fluid that is delivered directly into a vein. It is an approved, short‑acting beta‑blocker that is increasingly used in hospitals for fast control of heart rate after heart surgery. The primary purpose is to lower the risk of new irregular heartbeats (atrial fibrillation) that can occur after cardiac operations. It works by selectively blocking beta‑1 receptors in the heart, which slows the heart’s rhythm without affecting other parts of the body, and it is classified as an ultra‑short‑acting beta‑blocker.
Investigated diseases
Postoperative atrial fibrillation - Postoperative atrial fibrillation is an irregular, rapid heartbeat that begins after heart surgery. It typically appears within the first week following the operation and may last from a few minutes to several days. The condition often starts as brief episodes that can become more frequent or sustained. It is caused by changes in the heart’s electrical activity due to surgical stress and inflammation. Over time, episodes may resolve on their own or become recurrent, requiring monitoring.
Trial detailsLast updated 18 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2025-524518-26-03Protocol code2024-12-014Estimated enrolment400 patientsSponsorGCS Ramsay Sante Enseignement Et Recherche
sourced from the EU Clinical Trials Register and site verification
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