Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Study Overview
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Brief Summary
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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 : recent-onset atrial fibrillation versus iv flecainide 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

Official Title
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Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Conditions
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Atrial Fibrillation, Tachycardia, Ventricular, Brugada Syndrome

Intervention / Treatment
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* Drug: flecainide
* Drug: ajmaline
* Drug: procainamide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>IV flecainide in atrial fibrillation | Drug: flecainide<br>* 2 mg/kg iv in 10 minutes<br>|
| Experimental: B<br>IV ajmaline in atrial fibrillation | Drug: ajmaline<br>* 1 mg/kg iv in 10 minutes<br>|
| Active Comparator: c<br>iv procainamide in ventricular tachycardia | Drug: procainamide<br>* 10 mg/kg iv in 10 minutes<br>|
| Experimental: d<br>iv ajmaline in ventricular tachycardia | Drug: ajmaline<br>* 1 mg/kg iv in 10 minutes<br>|
| Active Comparator: e<br>iv flecainide in diagnosis of Brugada Sd | Drug: flecainide<br>* 2 mg/kg iv in 10 minutes<br>|
| Experimental: f<br>iv ajmaline in diagnosis of Brugada Sd | Drug: ajmaline<br>* 1 mg/kg iv in 10 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with reversion of atrial fibrillation |  | 1 hour | 
| Proportion of patients with reversion of ventricular tachycardia |  | 15 min | 
| Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test. |  | 1 hour |