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

NCT ID: NCT04223739

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-13
• Study Completion Date: 2022-06-01

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.

Detailed Description

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

Conditions

Atrial Fibrillation; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Landiolol

Intervention Type: 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.

Amiodarone

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

Group Type: ACTIVE_COMPARATOR

Amiodarone

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Rapibloc; Cordarone

Eligibility Criteria

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)

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

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edouard Caspersen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

Caen University Hospital

Caen, Calvados, France

Site Status: RECRUITING

Countries

France

Central Contacts

Edouard Caspersen, MD

Role: CONTACT

caspersen-e@chu-caen.fr

+33 02 31 06 47 36

Marc-Olivier Fischer, MD-PhD

Role: CONTACT

fischer-mo@chu-caen.fr

+33 02 31 06 47 36

Facility Contacts

Edouard Caspersen, MD

Role: primary

caspersen-e@chu-caen.fr

+33 02 31 06 47 36

References

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.

Reference Type: DERIVED

PMID: 37226174 (View on PubMed)

Other Identifiers

2019-A00763-54

Identifier Type: -

Identifier Source: org_study_id