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

NCT04607122 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Landiolol

Continuous infusion of landiolol starting at 1 µg/kg/min and increasing every 10-15 minutes with incremental doses of 0.5 µg/kg/min up to 2 µg/kg/min by maintaining MAP ≥ 65 mmHg and HR ≥ 50/min.

DRUG

Saline

Continuous infusion of saline solution at the same rate as landiolol infusion.

Sponsors & Collaborators

  • CMC Ambroise Paré

    lead OTHER

Principal Investigators

  • Julien Amour, MD, PhD · Hôpital Privé Jacques Cartier, Massy, France

  • Pierre Squara, MD · CMC Ambroise Paré, Neuilly-sur-Seine, France

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2023-06-30
Completion
2023-07-22

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04607122 on ClinicalTrials.gov