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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06262932
• Other study ID #: RADS regimen
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Police General Hospital, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Amiodarone
Assess the effectiveness of repeated bolus dosing strategies of amiodarone.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Police General Hospital, Thailand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Major adverse cardiovascular events	Number of MACE [MACE defined as acute myocardial infarction (AMI), stroke, or cardiovascular death]	30 days after receiving amiodarone bolus
Secondary	Phlebitis	Rate of phlebitis complication during amiodarone infusion	24-hours after receiving amiodarone bolus
Secondary	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