Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery

NCT04223739 | Unknown Phase 4

• 1 other identifier: 2019-A00763-54
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. However, management of postoperative atrial fibrillation is controversial. Two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone. Landiolol is a new-generation beta-blocker with a short half-life, which was approved by the Haute Autorité de Santé to be used in perioperative supra-ventricular tachycardias. Only one study compared landiolol to amiodarone in the perioperative setting, with a better hemodynamic tolerance and a higher rate of conversion to sinus rhythm with landiolol. However this was a single-center and retrospective study. The aim of our multicenter randomized study is to compare the effectiveness of landiolol in reducing atrial fibrillation to sinus rhythm compared to amiodarone in the postoperative period after cardiac surgery.

Conditions

Atrial Fibrillation; Cardiac Surgery

Keywords

Cardiac Surgery; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery

  Percentage of patients in sinus rhythm 48 hours after the onset of atrial fibrillation immediate postoperative period after cardiac surgery

  Day 2 after onset of atrial fibrillation

Secondary Outcomes (6)

• Haemodynamic side effects (hypotension, bradycardia)

  Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days

• Length of hospital stay

  Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days

• Rate of thrombo-embolic events

  2 months postsugery and 1 year postsurgery

• Quality of life evaluated by the EQ 5D 3L questionnaire

  2 months postsurgery and 1 year postsurgery

• Rate of atrial fibrillation recurrence

  2 months postsurgery and 1 year postsurgery

Study Arms (2)

Landiolol

ACTIVE COMPARATOR

Landiolol infusion starting at 2.5 µg/kg/min and titrating up to 80µg/kg/min with a heart rate goal of under 90 bpm.

Drug: Landiolol

Amiodarone

ACTIVE COMPARATOR

Amiodarone bolus of 5-7 mg/kg in 1 hour, followed by an infusion of 1g/day until conversion to sinus rhythm.

Drug: Amiodarone

Interventions

Landiolol DRUG

Landiolol infusion with incremental doses (range from 2,5µg/kg/min to 80 µg/kg/min) with go of heart rate \< 90 bpm. Doses are modified every 10 minutes if necessary. Once heart rate goal is obtained, switch to an oral dose of Bisoprolol.

Also known as: Rapibloc

Landiolol

Amiodarone DRUG

Amiodarone loading dose of 5-7 mg/kg in 1 hour followed by an infusion of 1 g/day until conversion to sinus rhythm. Once sinus rhythm is obtained, switch to an oral dose of 200mg/day

Also known as: Cordarone

Amiodarone

Eligibility Criteria

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

You may qualify if:

• Adult patients hospitalized in the cardiac ICU after having undergone cardiac surgery (CABG, aortic valve or ascending aortic root replacement or a combination of both)
• New onset of atrial fibrillation lasting more than 30 minutes in the postoperative period after cardiac surgery
• French speaking patients
• Written consent
• Patients with social security insurance

You may not qualify if:

• Hemodynamic instability requiring electrical cardioversion of atrial fibrillation
• Sepsis
• Bradyarrythmia (\< 90/min)
• Patients requiring inotropes in the postoperative period
• Patient with pre-existing atrial fibrillation
• Patient with anticoagulant therapy before surgery
• Contraindication to amiodarone or beta-blockers
• Urgent surgery (\< 24h), ventricular assist device, heart transplant, TAVR, mechanical valve, mitral or tricuspid valve replacement.
• No written consent
• Pregnant women,
• Underaged patients (\<18 years old)
• Patients not able to give consent (curators, patients deprived of public rights)

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, Calvados, 14000, France

RECRUITING

Related Publications (1)

• Caspersen E, Guinot PG, Rozec B, Oilleau JF, Fellahi JL, Gaudard P, Lorne E, Mahjoub Y, Besnier E, Moussa MD, Mongardon N, Hanouz JL, Briant AR, Paul LPS, Tomadesso C, Parienti JJ, Descamps R, Denisenko A, Fischer MO; ARCOTHOVA Group. Comparison of landiolol and amiodarone for the treatment of new-onset atrial fibrillation after cardiac surgery (FAAC) trial: study protocol for a randomized controlled trial. Trials. 2023 May 25;24(1):353. doi: 10.1186/s13063-023-07353-6.

  PMID: 37226174 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

landiolol; Amiodarone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Edouard Caspersen, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edouard Caspersen, MD

CONTACT

+33 02 31 06 47 36; caspersen-e@chu-caen.fr

Marc-Olivier Fischer, MD-PhD

CONTACT

+33 02 31 06 47 36; fischer-mo@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: January 10, 2020
• Study Start: December 13, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

FR (1)