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 fibrillationProportion 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 Cardiología, Hospital Clínic, 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
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