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

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Tachycardia, Ventricular; Brugada Syndrome
• Intervention / Treatment: Drug: flecainide; Drug: ajmaline; Drug: procainamide

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Servicio de Cardiología, Hospital Clínic
  • Madrid, Spain
    • Hospital Puerta de Hierro
  • Valencia, Spain
    • Hospital La Fe
  • Guipuzcoa
    • Donostia, Guipuzcoa, Spain
      • Hospital Donostia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: June 19, 2008
• First Submitted That Met QC Criteria: June 19, 2008
• First Posted (Estimate): June 20, 2008

Study Record Updates

• Last Update Posted (Estimate): December 15, 2010
• Last Update Submitted That Met QC Criteria: December 14, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiac Conduction System Disease; Atrial Fibrillation; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Brugada Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Flecainide; Procainamide; Ajmaline
• Other Study ID Numbers: AJUAR; EudraCT number:2007-006334-33