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OpenTrials
Completed

NCT Number: NCT06262932

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Police general hospital

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amiodarone

Drug

Assess the effectiveness of repeated bolus dosing strategies of amiodarone.

Primary outcomes

  1. Heart rate

    Time frame: 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 outcomes

  1. Normal sinus rhythm at 24 hours

    Time frame: 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

  2. Heart rate

    Time frame: 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

  3. Major adverse cardiovascular events

    Time frame: 30 days after receiving amiodarone bolus

    Number of MACE [MACE defined as acute myocardial infarction (AMI), stroke, or cardiovascular death]

  4. Phlebitis

    Time frame: 24-hours after receiving amiodarone bolus

    Rate of phlebitis complication during amiodarone infusion

  5. Changed in heart rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Police General Hospital, Thailand

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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