Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

NCT ID: NCT05543278

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-12-31

Brief Summary

Postoperative atrial fibrillation is quite common after cardiac surgery with up to 1 in 3 patients experiencing this abnormal heart rhythm. Amiodarone, a medication commonly used to treat atrial fibrillation, has been previously shown to be an effective prophylactic agent at decreasing the occurrence of postoperative atrial fibrillation in patients who underwent coronary artery bypass surgery. However, despite many studies which have demonstrated its effectiveness, it has not been widely used due to the concern of side effects that can occur such as slow heart rate, low blood pressure, and lung toxicity. We have designed a study to test the effectiveness and safety of a short course of postoperative prophylactic amiodarone for patients undergoing non-coronary artery bypass cardiac surgery. We hypothesize that patients who receive the prophylactic amiodarone will have decreased rates of postoperative atrial fibrillation without significantly increased side effects compared to patients who receive the standard postoperative care after non-coronary artery bypass cardiac surgery.

Conditions

Surgery, Cardiac; Atrial Fibrillation

Study Design

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

Study Groups

Amiodarone Arm

In addition to the regular care provided to cardiac surgery patients, those in the Amiodarone Arm will also receive the amiodarone regimen.

Group Type: EXPERIMENTAL

Amiodarone

Intervention Type: DRUG

Patients randomized to the Amiodarone Arm will receive a 5-day course of amiodarone after surgery.

Standard of Care Arm

Patients randomized to the Standard of Care Arm will receive the regular care provided to cardiac surgery patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Amiodarone

Patients randomized to the Amiodarone Arm will receive a 5-day course of amiodarone after surgery.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• >= 18 years of age
• All genders
• All non-coronary artery bypass cardiac surgery patients
• Preoperative normal sinus rhythm

Exclusion Criteria

• Pre-existing atrial fibrillation or atrial arrhythmias
• Pre-existing heart block
• Cardiogenic shock
• Sick sinus syndrome
• Marked sinus bradycardia
• Preoperative amiodarone use
• Contraindication to amiodarone use

• PR interval > 240 ms
• QTc > 550 ms
• 2nd or 3rd degree heart block
• Liver impairment (INR > 1.7, AST/ALT > 2x normal)
• Uncontrolled hyperthyroidism or hypothyroidism
• Interstitial lung disease
• Pregnancy and/or breastfeeding
• Known hypersensitivity to any components of amiodarone, including iodine
• Emergent operation
• Planned MAZE or Pulmonary Vein Isolation procedure

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

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Asishana A Osho

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asishana A Osho, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Central Contacts

Asishana A Osho, MD, MPH

Role: CONTACT

asishana.osho@mgh.harvard.edu

617-643-9745

References

Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039.

Reference Type: BACKGROUND

PMID: 28369234 (View on PubMed)

Arsenault KA, Yusuf AM, Crystal E, Healey JS, Morillo CA, Nair GM, Whitlock RP. Interventions for preventing post-operative atrial fibrillation in patients undergoing heart surgery. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003611. doi: 10.1002/14651858.CD003611.pub3.

Reference Type: BACKGROUND

PMID: 23440790 (View on PubMed)

Chatterjee S, Sardar P, Mukherjee D, Lichstein E, Aikat S. Timing and route of amiodarone for prevention of postoperative atrial fibrillation after cardiac surgery: a network regression meta-analysis. Pacing Clin Electrophysiol. 2013 Aug;36(8):1017-23. doi: 10.1111/pace.12140. Epub 2013 Apr 29.

Reference Type: BACKGROUND

PMID: 23627761 (View on PubMed)

Buckley MS, Nolan PE Jr, Slack MK, Tisdale JE, Hilleman DE, Copeland JG. Amiodarone prophylaxis for atrial fibrillation after cardiac surgery: meta-analysis of dose response and timing of initiation. Pharmacotherapy. 2007 Mar;27(3):360-8. doi: 10.1592/phco.27.3.360.

Reference Type: BACKGROUND

PMID: 17316148 (View on PubMed)

Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Jan 18;145(3):e18-e114. doi: 10.1161/CIR.0000000000001038. Epub 2021 Dec 9. No abstract available.

Reference Type: BACKGROUND

PMID: 34882435 (View on PubMed)

Colunga Biancatelli RM, Congedo V, Calvosa L, Ciacciarelli M, Polidoro A, Iuliano L. Adverse reactions of Amiodarone. J Geriatr Cardiol. 2019 Jul;16(7):552-566. doi: 10.11909/j.issn.1671-5411.2019.07.004.

Reference Type: BACKGROUND

PMID: 31447894 (View on PubMed)

Orr CF, Ahlskog JE. Frequency, characteristics, and risk factors for amiodarone neurotoxicity. Arch Neurol. 2009 Jul;66(7):865-9. doi: 10.1001/archneurol.2009.96.

Reference Type: BACKGROUND

PMID: 19597088 (View on PubMed)

Wolkove N, Baltzan M. Amiodarone pulmonary toxicity. Can Respir J. 2009 Mar-Apr;16(2):43-8. doi: 10.1155/2009/282540.

Reference Type: BACKGROUND

PMID: 19399307 (View on PubMed)

Other Identifiers

2022P001732

Identifier Type: -

Identifier Source: org_study_id