Landiolol in Postoperative Atrial Fibrillation

NCT ID: NCT03779178

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-17
• Study Completion Date: 2019-12-04

Brief Summary

Postoperative atrial fibrillation is a common complication after cardiac surgery and is associated with an elevation of morbidity and mortality. The recommended treatment includes heart rate control with a beta blocker. Landiolol is a new-generation beta-blocker with favourable pharmacologic properties making an interesting drug to treat postoperative atrial fibrillation. However, Landiolol micro and macrocirculatory effects in the setting of atrial fibrillation are yet to describe. The aim of this study is to describe microcirculatory effects of incremental doses of landiolol in postoperative atrial fibrillation compared to a placebo. Our hypothesis is Landiolol will improve microcirculation disorders.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Landiolol group

Landiolol perfusion in incremental doses (range 0.5 to 10 µg/kg/min) over 2 hours

Group Type: EXPERIMENTAL

Landiolol

Intervention Type: DRUG

Landiolol perfusion over 120 minutes in incremental doses : 0.5, 1, 2, 5 and 10 µg/kg/min. Doses are modified every 20 minutes

Placebo group

Placebo perfusion in incremental doses (range 0.03 to 0.6 mL/kg/h) over 2 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo perfusion is sodium chloride NaCl 0.9% over 120 minutes in incremental doses : 0.03, 0.06, 0.12, 0.3 and 0.6 mL/kg/h. Doses are modified every 20 minutes. Perfusion are similar in landiolol group to preserve blind.

Interventions

Landiolol

Landiolol perfusion over 120 minutes in incremental doses : 0.5, 1, 2, 5 and 10 µg/kg/min. Doses are modified every 20 minutes

Intervention Type: DRUG

Placebo

Placebo perfusion is sodium chloride NaCl 0.9% over 120 minutes in incremental doses : 0.03, 0.06, 0.12, 0.3 and 0.6 mL/kg/h. Doses are modified every 20 minutes. Perfusion are similar in landiolol group to preserve blind.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient underwent conventional cardiac surgery
• Age > 18 years
• Writing contentment

Exclusion Criteria

• Pre-existing chronic atrial fibrillation
• Contraindication to beta-blockers
• Circulatory shock (cardiac index<2.2 L/min and lactate>4mmol/L)
• Distributive shock (cardiac index>2.2 L/min with norepinephrine dose > 0.3 µg/kg/min to reach mean arterial pressure > 65mmHg).
• Acute respiratory distress
• Major bleeding (>200mL/h)
• Patient already included into an interventional clinical study
• Pregnancy
• No social security insurance
• Patient not able to give consent (curators, patients deprived of public rights)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthias Jacquet-Lagrèze

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital Louis Pradel

Bron, , France

Countries

France

References

Ferraris A, Jacquet-Lagreze M, Cazenave L, Fornier W, Jalalzai W, Rousseau-Saine N, Allaouchiche B, Junot S, Pozzi M, Fellahi JL; Anesthesie-Reanimation Coeur-Thorax-Vaisseaux (ARCOTHOVA) Group. Microcirculatory effects of landiolol: a double-blind, randomised, controlled study after cardiac surgery. Br J Anaesth. 2021 Jun;126(6):e212-e214. doi: 10.1016/j.bja.2021.03.013. Epub 2021 Apr 24. No abstract available.

Reference Type: RESULT

PMID: 33902917 (View on PubMed)

Other Identifiers

2018-000307-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

69HCL16_0743

Identifier Type: -

Identifier Source: org_study_id