Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Phase 4

Completed

• Conditions: Atrial Fibrillation; Tachycardia, Ventricular; Brugada Syndrome
• Interventions: Drug: procainamide; Drug: ajmaline; Drug: flecainide

• Registration Number: NCT00702117
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-12-14
• Last Update Posted: 2010-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
c	procainamide	iv procainamide in ventricular tachycardia
B	ajmaline	IV ajmaline in atrial fibrillation
A	flecainide	IV flecainide in atrial fibrillation
d	ajmaline	iv ajmaline in ventricular tachycardia
e	flecainide	iv flecainide in diagnosis of Brugada Sd
f	ajmaline	iv ajmaline in diagnosis of Brugada Sd

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Hospital Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Donostia; 🇪🇸 Donostia, Guipuzcoa, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Servicio de Cardiología, Hospital Clínic; 🇪🇸 Barcelona, Spain