Prevention of Atrial Fibrillation by Low-dose Landiolol Administration After Cardiac Surgery

• Status: Recruiting
• Trial end date: 2023-01-28
• Target enrollment: 0
• Participant gender: All

Summary

Postoperative atrial fibrillation (POAF) is a common complication that occurs in 30-50% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. During the perioperative period, the discontinuation of beta-blocker treatment is known to be a risk factor for developing POAF in patient undergoing cardiac surgery. Early beta-blocker reintroduction is associated with lower incidence of POAF. Unfortunately, side effects of currently available beta-blockers (including esmolol), such as low blood pressure and excessive bradycardia and/or their extended duration of action, limit their use in the post-operative period especially for prevention.

Landiolol, an ultra-short acting injectable beta-blocker, offers the advantage of significantly limiting low blood pressure events while increasing therapeutic efficacy in the treatment of POAF in cardiac and non-cardiac surgery. Landiolol, when used at low dose in the postoperative period, has been showed to reduce the incidence of POAF with no increased incidence of side effect as compared to standard of care. The limitation is that these promising data come from single center studies with limited samples and conducted exclusively in Japanese population. If landiolol is approved for use in the treatment of atrial fibrillation in non-Asian patients, there are no data on the prevention of POAF in cardiac surgery.

The objective of this multicenter, double-blind, randomized, placebo- controlled phase III trial is to confirm that landiolol postoperative infusion is associated with lower incidence of POAF without excess of adverse events as compared to standard of care in a non-Asian population after cardiac surgery with sternotomy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CMC Ambroise Paré
• Treatments: Landiolol

Criteria

Inclusion Criteria:

• Non-Asian,

• Undergoing cardiac surgery with CPB,

• Left ventricular ejection fraction (LVEF) ≥ 40%,

• Having signed a written informed consent form,

• Affiliation to the social security system.

Preoperative Exclusion Criteria:

• Paroxystic or persistant atrial fibrillation before surgery,

• Preoperative contraindication to beta-blockers,

• Known hypersensitivity to landiolol,

• Severe conduction disorders (atrio-ventricular conduction block),

• A mental or linguistic inability to understand the study,

• Dying patient,

• Patient under protection of the adults (guardianship, curators or safeguard of justice),

• Patient included or planning to be included in another research protocol relating to medications.

Postoperative Exclusion Criteria:

• Postoperative contraindication to beta-blockers: severe sinus bradycardia requiring pacing, postcardiotomy low cardiac output requiring inotropic agents (noradrenaline being not considered as an inotropic agent), severe hypotension, severe acute pulmonary hypertension, reoperation for significant bleeding (> 200 ml/h), acute respiratory distress syndrome defined by increased oxygen dependence, a PaO2/FiO2 ratio < 200, polypnea > 30 /min, signs of respiratory distress (retractions, thoraco-abdominal asynchrony).