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Antiarrhythmic Agent

Amiodarone to Prevent Post-operative Atrial Fibrillation (PREP-AF Trial)

Q: What therapeutic conditions does Amiodarone typically address?

<p>Amiodarone can be utilized to treat <a href="https://www.withpower.com/clinical-trials/atrial-fibrillation">atrial fibrillation</a>, tachycardia, cardiothoracic surgery, and ventricular issues.</p>

N/A

Recruiting

Led By Andrew JE Seely, MD, PhD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing major non-cardiac pulmonary or esophageal surgery (including esophagectomy, pulmonary wedge resection, lobar resection, pneumonectomy, or gastrectomy)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upon study completion, 1 year following study initiation

Awards & highlights

PREP-AF Trial Summary

This trial will assess the feasibility and safety of administering amiodarone to patients who are at high risk for developing atrial fibrillation after surgery.

Who is the study for?

This trial is for adults over 18 undergoing major lung or esophagus surgery who are at high risk of developing atrial fibrillation post-operation, as indicated by a prediction score. It excludes those with a history of certain heart conditions, current antiarrhythmic therapy, previous severe reaction to amiodarone, specific liver issues, and allergies to amiodarone.Check my eligibility

What is being tested?

The study tests the safety and feasibility of using Amiodarone versus a placebo in preventing irregular heart rhythm after lung or esophagus surgery in patients identified as high-risk. Participants will be randomly assigned to receive either Amiodarone or a placebo.See study design

What are the potential side effects?

Amiodarone can cause side effects such as issues with lung function (interstitial lung disease), liver toxicity (hepatotoxicity), changes in heart rhythm due to prolonged QTc interval, among others.

PREP-AF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for major lung or esophagus surgery.

PREP-AF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upon study completion, 1 year following study initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upon study completion, 1 year following study initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and upon study completion, 1 year following study initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to safety protocol

Capability for enrolment

Intervention delivery

+5 more

Secondary outcome measures

Hospital length of stay

Incidence of postoperative atrial fibrillation

Side effects data

From 2008 Phase 4 trial • 130 Patients • NCT00127712

34%

Hypotension

death

100%

80%

60%

40%

20%

Study treatment Arm

Control

Amiodarone

PREP-AF Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention ArmExperimental Treatment1 Intervention

Patients randomized to amiodarone treatment

Group II: Control ArmPlacebo Group1 Intervention

Patients randomized to placebo treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Amiodarone

2010

Completed Phase 4

~5380

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

563 Previous Clinical Trials

2,787,637 Total Patients Enrolled

6 Trials studying Atrial Fibrillation

5,733 Patients Enrolled for Atrial Fibrillation

Andrew JE Seely, MD, PhDPrincipal InvestigatorThe Ottawa Hospital

3 Previous Clinical Trials

322 Total Patients Enrolled

Media Library

Amiodarone (Antiarrhythmic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04392921 — N/A

Atrial Fibrillation Research Study Groups: Control Arm, Intervention Arm

Atrial Fibrillation Clinical Trial 2023: Amiodarone Highlights & Side Effects. Trial Name: NCT04392921 — N/A

Amiodarone (Antiarrhythmic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04392921 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the central aim of this scientific experiment?

"This medical trial's primary objective is to assess adherence to safety protocols over a one-year period following study initiation. Secondary evaluations will include severity of postoperative atrial fibrillation according the Clavien-Dindo classification schema and Ottawa Thoracic Morbidity and Mortality system, other postoperative complications as identified by the taxonomy of the Ottawa Thoracic Morbidity and Mortality definitions, along with recording incidence of postoperative atrial fibrillation proved by electrocardiogram with an irregular narrow complex tachycardia without p waves. Post-op mortality (grade V) must also be noted alongside"

Answered by AI

Are there any opportunities left to join this experiment?

"Affirmative. According to clinicaltrials.gov, this research endeavor which was published on March 7th 2022 is actively looking for participants. 80 people will be accepted at one medical centre as part of the study's data collection process."

Answered by AI

What is the aggregate enrollment rate for this clinical experiment?

"Affirmative. The information hosted on clinicaltrials.gov reveals that this study is currently recruiting patients, with its first posting date of March 7th 2022 and most recent update occurring on the 14th of the same month. This trial seeks 80 participants from a single medical centre."

Answered by AI