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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06262932

Enrollment

Registered

2024-02-16

Start date

2024-05-01

Completion date

2024-12-31

Last updated

2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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

Interventions

DRUGAmiodarone

Assess the effectiveness of repeated bolus dosing strategies of amiodarone.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Heart rate	6-hours after receiving amiodarone bolus	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

Secondary

Measure	Time frame	Description
Normal sinus rhythm at 24 hours	24-hours after receiving amiodarone bolus	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
Heart rate	24-hours after receiving amiodarone bolus	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
Major adverse cardiovascular events	30 days after receiving amiodarone bolus	Number of MACE \[MACE defined as acute myocardial infarction (AMI), stroke, or cardiovascular death\]
Phlebitis	24-hours after receiving amiodarone bolus	Rate of phlebitis complication during amiodarone infusion
Changed in heart rate	24-hours after receiving amiodarone bolus	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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026