2025-524518-26-03Not yet recruitingPhase 3
Optimizing Postoperative Betablockade with Landiolol on top of oral betablocker to prevent New-Onset Atrial Fibrillation Following Cardiac Surgery in Caucasian patients
Optimizing Postoperative Betablockade with Landiolol on top of oral betablocker to prevent New-Onset Atrial Fibrillation Following Cardiac Surgery in Caucasian patients: A multicenter, randomized, double-blind study.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Oct 2026
Brief summary (registry, in English)
To evaluate the effect of a preventive infusion of landiolol versus placebo on the incidence of postoperative atrial fibrillation within 7 days following cardiac surgery in Caucasian patients.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 1 Sept 2026
- Lead sponsor
- GCS Ramsay Sante Enseignement Et Recherche
- Diseases
- Atrial fibrillation
- EU CT number
- 2025-524518-26-03
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for Caucasian adults aged 65 and older who are scheduled for planned heart surgery with a heart-lung machine. It tests whether landiolol, given on top of an oral beta-blocker, prevents new atrial fibrillation after surgery.
- Age
- 65 years and older
- Sex
- All sexes can join.
- Disease stage
- Planned (elective) heart surgery using cardiopulmonary bypass, with a left ventricular ejection fraction of 50% or higher before surgery.
- Earlier treatment
- The record says the patients take an oral beta-blocker. It names no other treatment people must have had.
Main reasons for not taking part
- Atrial fibrillation before surgery (paroxysmal or persistent)
- Cannot take beta-blockers, or known allergy to landiolol
- Severe heart conduction or rhythm problem (complete atrioventricular block or bradycardia needing external pacing)
- Shock after heart surgery needing adrenaline or dobutamine, or vasoplegic syndrome
- Acute respiratory distress syndrome or a moribund condition (SAPS II above 90)
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of paroxysmal or persistent atrial fibrillation prior to surgery
Other illness
- Contraindication to beta-blockers or known hypersensitivity to landiolol
- Severe conduction or cardiac rhythm disorder (complete atrioventricular block or bradycardia requiring external pacing
- Vasoplegic syndrome defined by a MAP < 65 mmHg despite vasopressor support with noradrenaline ≥ 0.3 μg.kg⁻¹.min⁻¹ and volume optimization
- Acute respiratory distress syndrome defined by a PaO2/FiO2 ratio < 200
Age
- Patient under 65 years of age
Other
- Patient under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision, or hospitalized without consent
- Patient unable to personally provide consent or legally protected adult
- Post-cardiotomy cardiogenic shock requiring inotropic agents (adrenaline, dobutamine)
- Moribund patient defined by a Simplified Acute Physiology Score II (SAPS II) greater than 90
- Mental or linguistic inability to understand the study
Who the study is looking for
- Patient aged 65 years and older
- Caucasian patient
- Patient scheduled for elective cardiac surgery under cardiopulmonary bypass with a preoperative left ventricular ejection fraction of ≥ 50%
- Patient affiliated with a social security scheme or equivalent
- Free, informed and signed consent
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Privé Jacques Cartier | Massy | France | Not yet recruiting |
| Centre Medico Chirurgical Ambroise Pare Hartmann | Neuilly-Sur-Seine | France | Not yet recruiting |
| Societe D'Exploitation Du Centre Cardiologique Du Nord | Saint-Denis | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.