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Time-dependent Amiodarone Treatment in Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Intravenous amiodarone(1)
Intravenous amiodarone(2)
Sponsored by
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Intravenous Amiodarone, Drug safety profile, Chemical cardioversion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario "Dr. José Eleuterio González". Universidad Autónoma de Nuevo León

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

24h infusion

72h infusion

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Obtain a continuous sinus rhythm
Monitoring using continuous telemetry.

Secondary Outcome Measures

Complication rate of continuous amiodarone intravenous infusion
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.

Full Information

First Posted
January 29, 2018
Last Updated
February 12, 2018
Sponsor
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
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1. Study Identification

Unique Protocol Identification Number
NCT03432663
Brief Title
Time-dependent Amiodarone Treatment in Atrial Fibrillation
Official Title
Using Time-dependent Intravenous Infusions of Amiodarone for Conversions to Sinus Rhythms in Patients With Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2008 (Actual)
Primary Completion Date
November 30, 2009 (Actual)
Study Completion Date
November 30, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Intravenous Amiodarone, Drug safety profile, Chemical cardioversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
24h infusion
Arm Type
Experimental
Arm Description
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)
Arm Title
72h infusion
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Intravenous amiodarone(1)
Other Intervention Name(s)
24 hour amiodarone
Intervention Description
Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached
Intervention Type
Drug
Intervention Name(s)
Intravenous amiodarone(2)
Other Intervention Name(s)
72 hour amiodarone
Intervention Description
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
Primary Outcome Measure Information:
Title
Obtain a continuous sinus rhythm
Description
Monitoring using continuous telemetry.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Complication rate of continuous amiodarone intravenous infusion
Description
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.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis A Sanchez-Trujillo, MD
Organizational Affiliation
Escuela de Medicina y Ciencias de la Salud. Tecnológico de Monterrey. Monterrey. México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario "Dr. José Eleuterio González". Universidad Autónoma de Nuevo León
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Time-dependent Amiodarone Treatment in Atrial Fibrillation

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