Time-dependent Amiodarone Treatment in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Using Time-dependent Intravenous Infusions of Amiodarone for Conversions to Sinus Rhythms in Patients With Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432663
• Other study ID #: 2017-LS002
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2018
• Last updated: February 12, 2018
• Start date: August 1, 2008
• Est. completion date: November 30, 2009

Study information

• Verified date: February 2018
• Source: Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2009
• Est. primary completion date: November 30, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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
• 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

Locations

Country	Name	City	State
Mexico	Hospital Universitario "Dr. José Eleuterio González". Universidad Autónoma de Nuevo León	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

Country where clinical trial is conducted

Mexico, 

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obtain a continuous sinus rhythm	Monitoring using continuous telemetry.	72 hours
Secondary	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.	72 hours