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NCT Number: NCT05543278

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amiodarone

Drug

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

Primary outcomes

  1. Postoperative atrial fibrillation

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

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

Secondary outcomes

  1. Operative mortality

    Time frame: Either in-hospital or within 30 days of procedure

    Operative mortality as defined by either in-hospital death or death within 30 days of discharge.

  2. Stroke

    Time frame: Either in-hospital or within 30 days of procedure

    characterized by deficits lasting > 24 hours and/or imaging findings of infarction

  3. Transient ischemic attack

    Time frame: Either in-hospital or within 30 days of procedure

    characterized by examination findings lasting < 24 hours without associated imaging findings

  4. Electrical cardioversion

    Time frame: Either in-hospital or within 30 days of procedure

    Whether the patient required electrical cardioversion for hemodynamically unstable atrial fibrillation

  5. Hemodynamic instability

    Time frame: Either in-hospital or within 30 days of procedure

    New hemodynamic instability (mean arterial pressure < 65 mmHg) after surgery

  6. Initiation of systemic anticoagulation

    Time frame: Either in-hospital or within 30 days of procedure

    New indication of systemic anticoagulation for stroke prophylaxis due to atrial fibrillation

  7. Myocardial infarction

    Time frame: Either in-hospital or within 30 days of procedure

    Myocardial infarction diagnosed based on ECG and laboratory testing including pursued intervention and/or findings from subsequent angiography will be compared between intervention groups. To be considered a myocardial infarction, the diagnosis will have to be confirmed and documented in the chart by a board-certified cardiologist.

  8. Persistence of atrial fibrillation at discharge

    Time frame: Up to 90 days

    Atrial fibrillation as diagnosed by final ECG

  9. Postoperative hospital length of stay

    Time frame: Up to 90 days

    The postoperative length of stay will be calculated starting from the end of the procedure to time of discharge.

  10. Readmission

    Time frame: Within 30 days of procedure

    Rates of hospital readmission will be estimated for patients in each of the study intervention groups. Readmissions will be counted in this calculation if patients are admitted to the hospital. Emergency room visits without admission and outpatient visits will not count toward this calculation of readmission rates.

  11. Symptomatic bradycardia

    Time frame: Either in-hospital or within 30 days of procedure

    Symptomatic bradycardia (HR < 55 bpm) requiring intervention

  12. Number of patients with Amiodarone-related pulmonary toxicity

    Time frame: Either in-hospital or within 30 days of procedure

    Clinical diagnosis of amiodarone-related pulmonary toxicity that uses a combination of x-ray findings consistent with known amiodarone-related pulmonary toxicity and clinical findings including shortness of breath, non-productive cough, and other diagnoses have been excluded.

Study contacts

Contact information is provided by the study sponsor or research team.

Asishana A Osho, MD, MPH

CONTACT

[email protected]

617-643-9745

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: PATRONUS

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Sep 16, 2022
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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