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Time-dependent Amiodarone Treatment in Atrial Fibrillation

Sponsor
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud (Other)
Overall Status
Completed
CT.gov ID
NCT03432663
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
16
Actual Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sixty consecutive emergency patients with newly diagnosed Atrial Fibrillation were randomized into two groups. The first received intravenous amiodarone infusions continuously for 24 hours; the second received Amiodarone until sinus rhythms was reached or for up to 72 hours.

The efficacy and safety of administering intravenous infusions of amiodarone for up to 72 hours were investigated and compared to the efficacy and safety of administering a standard 24 hours infusion of amiodarone. Specifically, the use of up to 72 hours infusions was considered as a new strategy to improve rates of conversion to sinus rhythm without altering the safety profile of the drug.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous amiodarone(1)
  • Drug: Intravenous amiodarone(2)
 Phase 4

Detailed Description

An open randomized clinical trial was conducted that included 60 emergency adult patients who were candidates for drug cardioversion after first symptomatic episodes of AF.

The patients were randomized in equal proportions and sequentially placed in one of two treatment groups; no patient knew to which group he or she belonged. The first group received intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 hours was reached. The second group received intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 hours for up to 72 hours.

All patients were continuously monitored using electrocardiograms, and echocardiograms were performed within 24 hours after the randomized trial began. The exact time of each patient's cardioversion was documented. In addition, general laboratory tests, lipid profiles, thyroid profiles and chest X-rays were obtained for all patients.

A sample size of 30 subjects in each group was calculated. A conversion rate of 60% was assumed, according to literature, and an estimated increase to 90% was assumed for the experimental group to find differences with a power of 0.8 and an alpha error of 0.05.

The primary goal was to obtain was a sinus rhythm conversion rate. The secondary goal was to obtain a combined complication rate by noting various complications in the patients, such as phlebitis, symptomatic hypotension that required vasopressors, bradycardia, nausea, vomiting and any organ embolism.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
60 emergency adult patients who were candidates for drug cardioversion after first symptomatic episodes of Atrial fibrillation to either (1)24 hour continuous infusion or (2)72 hours continuous intravenous Amiodarone or until sinus rhythms was reached.60 emergency adult patients who were candidates for drug cardioversion after first symptomatic episodes of Atrial fibrillation to either (1)24 hour continuous infusion or (2)72 hours continuous intravenous Amiodarone or until sinus rhythms was reached.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Using Time-dependent Intravenous Infusions of Amiodarone for Conversions to Sinus Rhythms in Patients With Paroxysmal Atrial Fibrillation
Actual Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Nov 30, 2009
Actual Study Completion Date :
Nov 30, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 24h infusion

Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached Intravenous amiodarone (1)

Drug: Intravenous amiodarone(1)
Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached
Other Names:
  • 24 hour amiodarone

    		•
    Experimental: 72h infusion

    Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 h for up to 72 h or until sinus rhythm was reached Intravenous amiodarone (2)

    Drug: Intravenous amiodarone(2)
    Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 h for up to 72 h or until sinus rhythm was reached
    Other Names:
  • 72 hour amiodarone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Obtain a continuous sinus rhythm [72 hours]

      Monitoring using continuous telemetry.

    Secondary Outcome Measures

    1. Complication rate of continuous amiodarone intravenous infusion [72 hours]

      Obtain a combined complication rate by noting various complications in the patients, such as phlebitis, symptomatic hypotension that required vasopressors, bradycardia, nausea, vomiting and any organ embolism.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ≥18 years old

    • Emergency patients

    • First symptomatic episodes of Atrial Fibrillation

    Exclusion Criteria:

    • Hemodynamic instability,

    • Previous use of antiarrhythmic drugs

    • Use of digoxin seven or fewer days prior to the study

    • Active thyroid disease

    • Known adverse reactions to amiodarone

    • Other ventricular arrhythmias

    • Contraindications for anticoagulation

    • Acute renal failure

    • Chronic liver disease

    • Transaminase levels that were twice the normal levels

    • Acute pulmonary edema

    • Uncontrolled hypertension (> 180/110 mmHg)

    • Unstable angina

    • Patients who were pregnant and/or breast feeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario "Dr. José Eleuterio González". Universidad Autónoma de Nuevo León Monterrey Nuevo León Mexico 64460

    Sponsors and Collaborators

    • Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

    Investigators

    • Principal Investigator: Luis A Sanchez-Trujillo, MD, Escuela de Medicina y Ciencias de la Salud. Tecnológico de Monterrey. Monterrey. México

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
    ClinicalTrials.gov Identifier:
    NCT03432663
    Other Study ID Numbers:
    • 2017-LS002
    First Posted:
    Feb 14, 2018
    Last Update Posted:
    Feb 14, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
    Atrial Fibrillation
    Intravenous Amiodarone
    Drug safety profile
    Chemical cardioversion
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Amiodarone

    Study Results

    No Results Posted as of Feb 14, 2018