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

January 19, 2025 updated by: Chawit Lopimpisuth, Police General Hospital, Thailand

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6-hours after receiving amiodarone bolus

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
24-hours after receiving amiodarone bolus
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
24-hours after receiving amiodarone bolus
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]
30 days after receiving amiodarone bolus
Phlebitis
Time Frame: 24-hours after receiving amiodarone bolus
Rate of phlebitis complication during amiodarone infusion
24-hours after receiving amiodarone bolus
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
24-hours after receiving amiodarone bolus

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Police General Hospital, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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