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Surgery, CardiacPhase 4PATRONUSNCT05543278

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

A Phase 4 study testing Amiodarone in people with Surgery, Cardiac and Atrial Fibrillation, run by Massachusetts General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery, Cardiac, Atrial Fibrillation
What is being tested?
Amiodarone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
No sites listed yet
Study dates
Jan 2027to Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Pre-existing atrial fibrillation or atrial arrhythmias
  • Pre-existing heart block
  • Cardiogenic shock
  • Sick sinus syndrome
  • Marked sinus bradycardia
  • Preoperative amiodarone use
Show all 17Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Asishana A Osho, MD, MPH contact

617-643-9745

asishana.osho@mgh.harvard.edu

About this study

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.

Being tested
Amiodarone
Keywords
Postoperative atrial fibrillation, POAF
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmiodaroneDrug

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

Study groups in NCT05543278
Study groupRoleWhat they receive
Amiodarone ArmExperimentalIn addition to the regular care provided to cardiac surgery patients, those in the Amiodarone Arm will also receive the amiodarone regimen.
Receives: Drug: Amiodarone
Standard of Care ArmNo interventionPatients randomized to the Standard of Care Arm will receive the regular care provided to cardiac surgery patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (12)

  1. Operative mortality

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

    Measured: Either in-hospital or within 30 days of procedure

  2. Stroke

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

    Measured: Either in-hospital or within 30 days of procedure

  3. Transient ischemic attack

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

    Measured: Either in-hospital or within 30 days of procedure

  4. Electrical cardioversion

    Whether the patient required electrical cardioversion for hemodynamically unstable atrial fibrillation

    Measured: Either in-hospital or within 30 days of procedure

  5. Hemodynamic instability

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

    Measured: Either in-hospital or within 30 days of procedure

  6. Initiation of systemic anticoagulation

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

    Measured: Either in-hospital or within 30 days of procedure

  7. Myocardial infarction

    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.

    Measured: Either in-hospital or within 30 days of procedure

  8. Persistence of atrial fibrillation at discharge

    Atrial fibrillation as diagnosed by final ECG

    Measured: Up to 90 days

  9. Postoperative hospital length of stay

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

    Measured: Up to 90 days

  10. Readmission

    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.

    Measured: Within 30 days of procedure

  11. Symptomatic bradycardia

    Symptomatic bradycardia (HR < 55 bpm) requiring intervention

    Measured: Either in-hospital or within 30 days of procedure

  12. Number of patients with Amiodarone-related pulmonary toxicity

    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.

    Measured: Either in-hospital or within 30 days of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study startJan 2027 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
242 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05543278
Sponsor's protocol ID
2022P001732
Acronym
PATRONUS
Status last verified
Mar 2026
First submitted
9 Sep 2022
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 28369234

  • 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.

    PubMed 23440790

  • 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.

    PubMed 23627761

  • 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.

    PubMed 17316148

  • 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.

    PubMed 34882435

  • 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.

    PubMed 31447894

  • 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.

    PubMed 19597088

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

    PubMed 19399307

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Amiodarone in people with Surgery, Cardiac and Atrial Fibrillation, run by Massachusetts General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Asishana A Osho, MD, MPH (617-643-9745, asishana.osho@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative atrial fibrillation (time frame: At least 1 minute duration, occurring before or on postoperative day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05543278, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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