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

NCT05543278 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 2022P001732
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Postoperative atrial fibrillation; POAF

Outcome Measures

Primary Outcomes (1)

• Postoperative atrial fibrillation

  The occurrence of postoperative atrial fibrillation detected by continuous telemetry, 12-lead electrocardiogram, and/or continuous ambulatory monitoring device through postoperative day 7.

  At least 1 minute duration, occurring before or on postoperative day 7

Secondary Outcomes (12)

• Operative mortality

  Either in-hospital or within 30 days of procedure

• Stroke

  Either in-hospital or within 30 days of procedure

• Transient ischemic attack

  Either in-hospital or within 30 days of procedure

• Electrical cardioversion

  Either in-hospital or within 30 days of procedure

• Hemodynamic instability

  Either in-hospital or within 30 days of procedure

Study Arms (2)

Amiodarone Arm

EXPERIMENTAL

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

Drug: Amiodarone

Standard of Care Arm

NO INTERVENTION

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

Interventions

Amiodarone DRUG

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

Amiodarone Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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
• nd 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Related Publications (8)

• 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.

  PMID: 28369234 BACKGROUND

• 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.

  PMID: 23440790 BACKGROUND

• 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.

  PMID: 23627761 BACKGROUND

• 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.

  PMID: 17316148 BACKGROUND

• 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.

  PMID: 34882435 BACKGROUND

• 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.

  PMID: 31447894 BACKGROUND

• 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.

  PMID: 19597088 BACKGROUND

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

  PMID: 19399307 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

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

• Asishana A Osho, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 16, 2022
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03