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

Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery : a Randomized Multicenter Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Cardiac Surgery
• Intervention / Treatment: Drug: Landiolol; Drug: Amiodarone

Detailed Description

Randomized clinical study comparing landiolol and amiodarone for treatment of atrial fibrillation following cardiac surgery

• Study Type: Interventional
• Enrollment (Anticipated): 380
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Edouard Caspersen, MD; Phone Number: +33 02 31 06 47 36; Email: caspersen-e@chu-caen.fr
• Study Contact Backup: Name: Marc-Olivier Fischer, MD-PhD; Phone Number: +33 02 31 06 47 36; Email: fischer-mo@chu-caen.fr

Study Locations

• France
  • Calvados
    • Caen, Calvados, France, 14000
      • Recruiting
      • CAEN university Hospital
      • Contact: Edouard Caspersen, MD; Phone Number: +33 02 31 06 47 36; Email: caspersen-e@chu-caen.fr
      • Principal Investigator: Edouard Caspersen, MD
      • Sub-Investigator: Marc-Olivier Fischer, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Landiolol; 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; 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.; Other Names: Rapibloc
Active Comparator: Amiodarone; Amiodarone bolus of 5-7 mg/kg in 1 hour, followed by an infusion of 1g/day until conversion to sinus rhythm.	Drug: Amiodarone; 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; Other Names: Cordarone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemodynamic side effects (hypotension, bradycardia)	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	Length of stay in the hospital from randomisation to hospital discharge	Day 8 after onset of atrial fibrillation and through hospital discharge, an average of 14 days
Rate of thrombo-embolic events	Rate of stroke or ischemic embolism	2 months postsugery and 1 year postsurgery
Quality of life evaluated by the EQ 5D 3L questionnaire	Quality of life as evaluated by the EQ 5D 3L questionnaire	2 months postsurgery and 1 year postsurgery
Rate of atrial fibrillation recurrence	Percentage of patients having a recurrence of atrial fibrillation after the initial conversion to sinus rythm in the postoperative period	2 months postsurgery and 1 year postsurgery
Severe hemorrhagic complications due to anticoagulant therapy, as defined by the Haute Autorité de Santé	Hemorrhagic complications requiring surgery or interventional radiology Hemorrhagic complications responsible of hemodynamic instability (Systolic Arterial Pressure < 90 mmHg, or drop of more than 40 mmHg or Mean Arterial Pressure < 65 mmHg or signs of shock) Life threatening hemorrhagic complications (intracerebral, intramedullar or intraocular hemorrhage, hemothorax, abdominal hemorrhage, deep muscular hemorrhage	2 months postsurgery and 1 year postsurgery

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Edouard Caspersen, MD, University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cardiac Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Amiodarone; Landiolol
• Other Study ID Numbers: 2019-A00763-54

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No