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Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

NCT ID: NCT00702117

Last Updated: 2010-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-01-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation Tachycardia, Ventricular Brugada Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

IV flecainide in atrial fibrillation

Group Type ACTIVE_COMPARATOR

flecainide

Intervention Type DRUG

2 mg/kg iv in 10 minutes

B

IV ajmaline in atrial fibrillation

Group Type EXPERIMENTAL

ajmaline

Intervention Type DRUG

1 mg/kg iv in 10 minutes

c

iv procainamide in ventricular tachycardia

Group Type ACTIVE_COMPARATOR

procainamide

Intervention Type DRUG

10 mg/kg iv in 10 minutes

d

iv ajmaline in ventricular tachycardia

Group Type EXPERIMENTAL

ajmaline

Intervention Type DRUG

1 mg/kg iv in 10 minutes

e

iv flecainide in diagnosis of Brugada Sd

Group Type ACTIVE_COMPARATOR

flecainide

Intervention Type DRUG

2 mg/kg iv in 10 minutes

f

iv ajmaline in diagnosis of Brugada Sd

Group Type EXPERIMENTAL

ajmaline

Intervention Type DRUG

1 mg/kg iv in 10 minutes

Interventions

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flecainide

2 mg/kg iv in 10 minutes

Intervention Type DRUG

ajmaline

1 mg/kg iv in 10 minutes

Intervention Type DRUG

procainamide

10 mg/kg iv in 10 minutes

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Hospital Clinic de Barcelona

Locations

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Servicio de Cardiología, Hospital Clínic

Barcelona, Barcelona, Spain

Site Status

Hospital Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Site Status

Hospital Puerta de Hierro

Madrid, Madrid, Spain

Site Status

Hospital La Fe

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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EudraCT number:2007-006334-33

Identifier Type: -

Identifier Source: secondary_id

AJUAR

Identifier Type: -

Identifier Source: org_study_id