Optimizing Postoperative Betablockade with Landiolol on top of oral betablocker to prevent New-Onset Atrial Fibrillation Following Cardiac Surgery in Caucasian patients
Key facts
- Where
- Massy, Neuilly-Sur-Seine és Saint-Denis, FranciaországSee the 3 sites
- Phase
- 3. fázis
Where in Franciaország
- Hôpital Privé Jacques CartierMassy, FranciaországToborzás még nem indult
- Centre Medico Chirurgical Ambroise Pare HartmannNeuilly-Sur-Seine, FranciaországToborzás még nem indult
- Societe D'Exploitation Du Centre Cardiologique Du NordSaint-Denis, FranciaországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GCS Ramsay Sante Enseignement Et Recherche
- Trial code
- EU 2025-524518-26-03
- Record updated
- 2026. október 16.
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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.
Exclusion: History of paroxysmal or persistent atrial fibrillation prior to surgery; 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; Patient under 65 years of age; 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.