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

NCT06262932 | Completed Phase 4

• 1 other identifier: RADS regimen
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Normal sinus rhythm at 24 hours

  24-hours after receiving amiodarone bolus

• Heart rate

  24-hours after receiving amiodarone bolus

• Major adverse cardiovascular events

  30 days after receiving amiodarone bolus

• Phlebitis

  24-hours after receiving amiodarone bolus

• Changed in heart rate

  24-hours after receiving amiodarone bolus

Study Arms (2)

Repeated amiodarone bolus dosing regimen

ACTIVE COMPARATOR

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

Standard dosing regimen

ACTIVE COMPARATOR

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

Interventions

Amiodarone DRUG

Assess the effectiveness of repeated bolus dosing strategies of amiodarone.

Repeated amiodarone bolus dosing regimen; Standard dosing regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Police General Hospital, Thailand: lead

Study Sites (1)

Police general hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 16, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

TH (1)