Time-dependent Amiodarone Treatment in Atrial Fibrillation

NCT03432663 | Completed Phase 4

• 1 other identifier: 2017-LS002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Intravenous Amiodarone; Drug safety profile; Chemical cardioversion

Outcome Measures

Primary Outcomes (1)

• Obtain a continuous sinus rhythm

  Monitoring using continuous telemetry.

  72 hours

Secondary Outcomes (1)

• Complication rate of continuous amiodarone intravenous infusion

  72 hours

Study Arms (2)

24h infusion

EXPERIMENTAL

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)

72h infusion

EXPERIMENTAL

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)

Interventions

Intravenous amiodarone(1) DRUG

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

Also known as: 24 hour amiodarone

24h infusion

Intravenous amiodarone(2) 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

Also known as: 72 hour amiodarone

72h infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Emergency patients
• First symptomatic episodes of Atrial Fibrillation

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (42)

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MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Luis A Sanchez-Trujillo, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 14, 2018
• Study Start: August 1, 2008
• Primary Completion: November 30, 2009
• Study Completion: November 30, 2009
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

ME (1)