Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias (AJUAR)

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation; Tachycardia, Ventricular; Brugada Syndrome

Treatments: Drug: procainamide; Drug: ajmaline; Drug: flecainide

Study type: Interventional

Funder types: Other

Identifiers

NCT00702117

EudraCT number:2007-006334-33

AJUAR

Details and patient eligibility

About

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

Enrollment: 123 patients

Sex: All

Ages: 10 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 6 patient groups

A

Active Comparator group

Description:

IV flecainide in atrial fibrillation

Treatment:

Drug: flecainide

B

Experimental group

Description:

IV ajmaline in atrial fibrillation

Treatment:

Drug: ajmaline

c

Active Comparator group

Description:

iv procainamide in ventricular tachycardia

Treatment:

Drug: procainamide

d

Experimental group

Description:

iv ajmaline in ventricular tachycardia

Treatment:

Drug: ajmaline

e

Active Comparator group

Description:

iv flecainide in diagnosis of Brugada Sd

Treatment:

Drug: flecainide

f

Experimental group

Description:

iv ajmaline in diagnosis of Brugada Sd

Treatment:

Drug: ajmaline