Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Atrial Fibrillation Clinical Trial

— AJUAR  

Official title:

Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702117
• Other study ID #: AJUAR
• Secondary ID: EudraCT number:2
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2008
• Last updated: December 14, 2010
• Start date: June 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Brugada Syndrome
• Tachycardia
• Tachycardia, Ventricular

Intervention

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

Locations

Country	Name	City	State
Spain	Servicio de Cardiología, Hospital Clínic	Barcelona
Spain	Hospital Donostia	Donostia	Guipuzcoa
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with reversion of atrial fibrillation		1 hour	No
Primary	Proportion of patients with reversion of ventricular tachycardia		15 min	No
Primary	Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test.		1 hour	No