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Landiolol in Postoperative Atrial Fibrillation (MMELPOAF)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status and phase

Completed
Phase 3

Conditions

Atrial Fibrillation

Treatments

Drug: Placebo
Drug: Landiolol

Study type

Interventional

Funder types

Other

Identifiers

NCT03779178
69HCL16_0743
2018-000307-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

58 participants in 2 patient groups, including a placebo group

Landiolol group
Experimental group
Description:
Landiolol perfusion in incremental doses (range 0.5 to 10 µg/kg/min) over 2 hours
Treatment:
Drug: Landiolol
Placebo group
Placebo Comparator group
Description:
Placebo perfusion in incremental doses (range 0.03 to 0.6 mL/kg/h) over 2 hours
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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