Time-dependent Amiodarone Treatment in Atrial Fibrillation

NCT ID: NCT03432663

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-01
• Study Completion Date: 2009-11-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Intravenous amiodarone(1)

Intervention Type: DRUG

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

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)

Group Type: EXPERIMENTAL

Intravenous amiodarone(2)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

24 hour amiodarone; 72 hour amiodarone

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis A Sanchez-Trujillo, MD

Role: PRINCIPAL_INVESTIGATOR

Escuela de Medicina y Ciencias de la Salud. Tecnológico de Monterrey. Monterrey. México

Locations

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

Monterrey, Nuevo León, Mexico

Countries

Mexico

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Other Identifiers

2017-LS002

Identifier Type: -

Identifier Source: org_study_id