Effectiveness of Repeated Amiodarone Dosing Regimen Versus Standard Dosing Regimen in Atrial Fibrillation Patient With Rapid Ventricular Response

The goal of this clinical trial is to compare in atrial fibrillation patient with rapid ventricular response. The main question it aims to answer are Effectiveness of Repeated Amiodarone dosing regimen versus standard dosing regimen in Atrial fibrillation patient with rapid ventricular response Participants will receive Amiodarone iv treatment with different regimen

• Repeated dosing regimen
• Standard dosing regimen

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Amiodarone

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Police General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age above 18 years old
• Atrial fibrillation with rapid ventricular response patient (ventricular rate > 110)

Exclusion Criteria:

• Baseline EKG Corrected QT interval (QTc) < 500 msec
• History of pulmonary fibrosis
• History of Cirrhosis
• Cardiac Index <2.2 L/min/m2 or Cardiogenic shock
• Unstable arrhythmia
• Receive amiodarone within 3 months prior to present illness
• Pregnancy
• Amiodarone or Iodine allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Repeated amiodarone bolus dosing regimen; An Initial 150 mg IV amiodarone bolus should be given over a 15-minute period. If the heart rate is still over 110 minutes after the initial treatment, provide an additional 150 mg IV amiodarone bolus over a 15-minute period. During the first 24 hours, this bolus may be administered up to three times in total. Within 24 hours of finishing the first bolus dosage, 900 mg of amiodarone will be administered intravenously.	Drug: Amiodarone; Assess the effectiveness of repeated bolus dosing strategies of amiodarone.
Active Comparator: Standard dosing regimen; An Initial 150 mg IV amiodarone bolus should be given over a 15-minute period, then a 24-hour amiodarone loading infusion 900 mg over 24 hours	Drug: Amiodarone; Assess the effectiveness of repeated bolus dosing strategies of amiodarone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Percentage of patients who have Atrial fibrillation with rapid ventricular response, the percentage of patients who have heart rate below 110 bpms at 6 hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have heart rate below 110 bpms at 6 hour after a conventional amiodarone IV loading dose regimen	6-hours after receiving amiodarone bolus

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal sinus rhythm at 24 hours	Percentage of patients who develop Atrial fibrillation with rapid ventricular response, the percentage of patients who have converted to sinus rhythm at 24-hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have converted to sinus rhythm after a conventional amiodarone IV loading dose regimen	24-hours after receiving amiodarone bolus
Heart rate	Percentage of patients who have Atrial fibrillation with rapid ventricular response, the percentage of patients who have heart rate below 110 bpms at 24 hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have heart rate below 110 bpms at 6 hour after a conventional amiodarone IV loading dose regimen	24-hours after receiving amiodarone bolus
Major adverse cardiovascular events	Number of MACE [MACE defined as acute myocardial infarction (AMI), stroke, or cardiovascular death]	30 days after receiving amiodarone bolus
Phlebitis	Rate of phlebitis complication during amiodarone infusion	24-hours after receiving amiodarone bolus
Changed in heart rate	Compare number of total heart rate induction in patients who received a repeated amiodarone bolus and loading dose regimen and a conventional amiodarone IV loading dose regimen at 24 hrs	24-hours after receiving amiodarone bolus

Collaborators and Investigators

• Sponsor: Police General Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Arrhythmia Agents; Sodium Channel Blockers; Membrane Transport Modulators; Cytochrome P-450 Enzyme Inhibitors; Vasodilator Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 CYP2D6 Inhibitors; Potassium Channel Blockers; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Amiodarone
• Other Study ID Numbers: RADS regimen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No