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Repeated amiodarone bolus dosing regimen (RBDR) for Atrial Fibrillation (RADICAL Trial)

Phase 4

Waitlist Available

Led By Kevin Hatton, MD

Research Sponsored by Kevin W Hatton, MD, PhD

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-hours after receiving amiodarone bolus

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing two ways of giving amiodarone to patients who develop an irregular heartbeat after heart surgery. The medication helps slow down the heart rate and restore normal rhythm.

Eligible Conditions

Atrial Fibrillation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-hours after receiving amiodarone bolus

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-hours after receiving amiodarone bolus

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-hours after receiving amiodarone bolus for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Normal Sinus Rhythm -24 HRS

Secondary study objectives

Normal Sinus Rhythm -Hospital Index

Recurrent AF

Time to Target Heart Rate

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Repeated amiodarone bolus dosing regimen (RBDR)Active Control1 Intervention

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.

Group II: Conventional amiodarone dosing regimen (CDR)Active Control1 Intervention

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.

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