Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias - Full Text View

Sponsor:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00702117

Purpose

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 :

recent-onset atrial fibrillation versus iv flecainide
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

Condition	Intervention	Phase
Atrial Fibrillation Tachycardia, Ventricular Brugada Syndrome	Drug: flecainide Drug: ajmaline Drug: procainamide	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome catecholaminergic polymorphic ventricular tachycardia familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

Drug Information available for: Procainamide Lorajmine Flecainide Flecainide acetate Procainamide hydrochloride Ajmaline

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Proportion of patients with reversion of atrial fibrillation [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Proportion of patients with reversion of ventricular tachycardia [ Time Frame: 15 min ] [ Designated as safety issue: No ]
Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment:	123
Study Start Date:	June 2008
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A IV flecainide in atrial fibrillation	Drug: flecainide 2 mg/kg iv in 10 minutes
Experimental: B IV ajmaline in atrial fibrillation	Drug: ajmaline 1 mg/kg iv in 10 minutes
Active Comparator: c iv procainamide in ventricular tachycardia	Drug: procainamide 10 mg/kg iv in 10 minutes
Experimental: d iv ajmaline in ventricular tachycardia	Drug: ajmaline 1 mg/kg iv in 10 minutes
Active Comparator: e iv flecainide in diagnosis of Brugada Sd	Drug: flecainide 2 mg/kg iv in 10 minutes
Experimental: f iv ajmaline in diagnosis of Brugada Sd	Drug: ajmaline 1 mg/kg iv in 10 minutes

Eligibility

Ages Eligible for Study:	10 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702117

Locations

Spain
Hospital Donostia
Donostia, Guipuzcoa, Spain
Servicio de Cardiología, Hospital Clínic
Barcelona, Spain, 08036
Hospital Puerta de Hierro
Madrid, Spain
Hospital La Fe
Valencia, Spain

Sponsors and Collaborators

Hospital Clinic of Barcelona

More Information

No publications provided

Responsible Party:	José Brugada, Hospital Clinic de Barcelona
ClinicalTrials.gov Identifier:	NCT00702117 History of Changes
Other Study ID Numbers:	AJUAR, EudraCT number:2007-006334-33
Study First Received:	June 19, 2008
Last Updated:	December 14, 2010
Health Authority:	Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Atrial Fibrillation
Tachycardia
Tachycardia, Ventricular
Brugada Syndrome
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Genetic Diseases, Inborn
Ajmaline
Flecainide
Procainamide
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012