Treatment for Atrial Fibrillation

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Kentucky Medical Center, Lexington, KY
Atrial Fibrillation
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new dosing regimen for amiodarone might be more effective than the conventional dosing regimen.

See full description

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Atrial Fibrillation

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 4 secondary outcomes in patients with Atrial Fibrillation. Measurement will happen over the course of duration of ICU and hospital visit, up to 20 days.

24-hours after receiving amiodarone bolus
Normal Sinus Rhythm -24 HRS
Time to Target Heart Rate
Total Target Heart Rate Time
Day 20
Normal Sinus Rhythm -Hospital Index
Recurrent AF

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Atrial Fibrillation

Trial Design

2 Treatment Groups

Conventional amiodarone dosing regimen (CDR)
1 of 2
Repeated amiodarone bolus dosing regimen (RBDR)
1 of 2
Active Control

This trial requires 150 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Conventional amiodarone dosing regimen (CDR)
Drug
Initial amiodarone bolus of 150 mg IV over 10 minutes then a 24-hour amiodarone loading infusion (1 mg/min for 6 hours followed by 0.5 mg/min for 18 hours), followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.
Repeated amiodarone bolus dosing regimen (RBDR)
Drug
Initial amiodarone bolus of 150 mg IV over 10 minutes, then 1.0 mg/min IV amiodarone infusion for 6 hours, then a 0.5 mg/min IV amiodarone infusion for 18 hours, followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. In addition, patients in the RBDR will receive an additional 150 mg IV amiodarone bolus whenever the patient develops tachycardia (Heart Rate (HR) = 110 beats per minute) lasting more than 10 minutes. This bolus may be repeated up to a total of 5 times (6 total boluses) over the first 24 hours. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24-hours after receiving amiodarone bolus
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24-hours after receiving amiodarone bolus for reporting.

Closest Location

University of Kentucky Medical Center - Lexington, KY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subject must be 18 years old or older
Subject must be willing to give written informed consent
Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or septal defect repair, thoracic aortic replacement surgery, or any combination of these procedures

Patient Q&A Section

Ask a question about the study

Other questions from users

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

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Atrial Fibrillation by sharing your contact details with the study coordinator.