Landiolol in Postoperative Atrial Fibrillation

NCT03779178 | Completed Phase 3

• 2 other identifiers: 69HCL16_07432018-000307-17
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

landiolol; microcirculation; cardiac surgery; atrial fibrillation

Outcome Measures

Primary Outcomes (6)

• Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

  Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.

  at 20 minutes

• Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

  Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.

  at 40 minutes

• Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

  Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.

  at 60 minutes

• Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

  Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.

  at 80 minutes

• Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

  Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.

  at 100 minutes

• Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)

  Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.

  at 120 minutes

Secondary Outcomes (22)

• Microcirculatory mean flow index (MIF) acquired by sublingual microscopy

  at 120 minutes

• proportion of perfused vessels acquired by sublingual microscopy

  at 120 minutes

• functional capillary density acquired by sublingual microscopy

  at 120 minutes

• De Backer score acquired by sublingual microscopy

  at 120 minutes

• heterogeneity of the mean flow index acquired by sublingual microscopy

  at 120 minutes

Study Arms (2)

Landiolol group

EXPERIMENTAL

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

Drug: Landiolol

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Landiolol 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

Landiolol group

Placebo 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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Louis Pradel

Bron, France

Location

Related Publications (1)

• 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.

  PMID: 33902917 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

landiolol

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthias Jacquet-Lagrèze

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 19, 2018
• Study Start: January 17, 2019
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: August 6, 2025

Record last verified: 2019-12

Locations

FR (1)