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Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Information source: Hospital Clinic of Barcelona
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation; Tachycardia, Ventricular; Brugada Syndrome

Intervention: flecainide (Drug); ajmaline (Drug); procainamide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hospital Clinic of Barcelona

Overall contact:
Jose Brugada, MD, Phone: +34932275703, Email: jbrugada@clinic.ub.es

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

Clinical Details

Official title: Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

Proportion of patients with reversion of atrial fibrillation

Proportion of patients with reversion of ventricular tachycardia

Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test.

Eligibility

Minimum age: 10 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Jose Brugada, MD, Phone: +34932275703, Email: jbrugada@clinic.ub.es

Servicio de CardiologĂ­a, Hospital ClĂ­nic, Barcelona 08036, Spain; Recruiting
Jose Brugada, MD, Phone: +34932275703, Email: jbrugada@clinic.ub.es
Jose Brugada, MD, Principal Investigator

Hospital Puerta de Hierro, Madrid, Spain; Recruiting
Ignacio Fernandez-Lozano, MD
Ignacio Fernandez-Lozano, MD, Principal Investigator

Hospital La Fe, Valencia, Spain; Active, not recruiting

Hospital Donostia, Donostia, Guipuzcoa, Spain; Recruiting
Jose M Porres, MD
Jose M Porres, MD, Principal Investigator

Additional Information

Starting date: June 2008
Ending date: December 2009
Last updated: January 28, 2009

Page last updated: October 19, 2009

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