Clinical trial NCT05543278: Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Official title: Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Surgery, Cardiac
Atrial Fibrillation
Keywords: Postoperative atrial fibrillation
POAF
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Postoperative atrial fibrillation
timeFrame: At least 1 minute duration, occurring before or on postoperative day 7
Secondary outcomes:
measure: Operative mortality
timeFrame: Either in-hospital or within 30 days of procedure
measure: Stroke
timeFrame: Either in-hospital or within 30 days of procedure
measure: Transient ischemic attack
timeFrame: Either in-hospital or within 30 days of procedure
measure: Electrical cardioversion
timeFrame: Either in-hospital or within 30 days of procedure
measure: Hemodynamic instability
timeFrame: Either in-hospital or within 30 days of procedure
measure: Initiation of systemic anticoagulation
timeFrame: Either in-hospital or within 30 days of procedure
measure: Myocardial infarction
timeFrame: Either in-hospital or within 30 days of procedure
measure: Persistence of atrial fibrillation at discharge
timeFrame: Up to 90 days
measure: Postoperative hospital length of stay
timeFrame: Up to 90 days
measure: Readmission
timeFrame: Within 30 days of procedure
measure: Symptomatic bradycardia
timeFrame: Either in-hospital or within 30 days of procedure
measure: Number of patients with Amiodarone-related pulmonary toxicity
timeFrame: Either in-hospital or within 30 days of procedure
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Asishana A Osho, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Wolkove N, Baltzan M. Amiodarone pulmonary toxicity. Can Respir J. 2009 Mar-Apr;16(2):43-8. doi: 10.1155/2009/282540.