Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Overview

The study evaluates 3 different populations: It is an open, randomized, parallel-group study comparing the effectiveness of intravenous (iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of : 1. recent-onset atrial fibrillation versus iv flecainide 2. sustained monomorphous ventricular tachycardia versus iv procainamide The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline versus iv flecainide in the diagnosis of Brugada syndrome

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2010

Interventions

  • Drug: flecainide
    • 2 mg/kg iv in 10 minutes
  • Drug: ajmaline
    • 1 mg/kg iv in 10 minutes
  • Drug: procainamide
    • 10 mg/kg iv in 10 minutes

Arms, Groups and Cohorts

  • Active Comparator: A
    • IV flecainide in atrial fibrillation
  • Experimental: B
    • IV ajmaline in atrial fibrillation
  • Active Comparator: c
    • iv procainamide in ventricular tachycardia
  • Experimental: d
    • iv ajmaline in ventricular tachycardia
  • Active Comparator: e
    • iv flecainide in diagnosis of Brugada Sd
  • Experimental: f
    • iv ajmaline in diagnosis of Brugada Sd

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients with reversion of atrial fibrillation
    • Time Frame: 1 hour
  • Proportion of patients with reversion of ventricular tachycardia
    • Time Frame: 15 min
  • Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test.
    • Time Frame: 1 hour

Participating in This Clinical Trial

Inclusion Criteria

  • AF: Patients with isolated, idiopathic, sustained, symptomatic, recent onset(>10 minutes to <24 hours) atrial fibrillation. – VT: Patients with ventricular tachycardia with good haemodynamic tolerability attending the emergency room or induced at the electrophysiology lab during testing for ventricular arrhythmias. – Brugada Sd (BrS): First-degree relatives of a patient with Brugada Syndrome with a ECG non-diagnostic of the BrS. Exclusion Criteria:

  • General: Pregnancy – AF: Pre-existing heart disease. – Secondary AF – 2nd and 3rd degree AV block or RBBB associated with LAFB or LPFB (bifascicular block). – LVF<40%. – Moderate-severe liver failure. – AF with haemodynamic compromise. – VT:VT with haemodynamic compromise. – BrS:Pre-existing heart disease. – 2nd and 3rd degree AV block or RBBB associated with LAFB or LPFB (bifascicular block). – Moderate-severe liver failure.

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Clinic of Barcelona
  • Provider of Information About this Clinical Study
    • José Brugada, Hospital Clinic de Barcelona

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