Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00702117

Acronym

AJUAR

Enrollment

123

Registered

2008-06-20

Start date

2008-06-30

Completion date

2010-01-31

Last updated

2010-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Tachycardia, Ventricular, Brugada Syndrome

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

Interventions

DRUGflecainide

2 mg/kg iv in 10 minutes

DRUGajmaline

1 mg/kg iv in 10 minutes

DRUGprocainamide

10 mg/kg iv in 10 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 80 Years

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.

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026