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

Sponsored by:	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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome 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 ]

Estimated Enrollment:	300
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Jose Brugada, MD

+34932275703

jbrugada@clinic.ub.es

Locations

Spain
Servicio de Cardiología, Hospital Clínic	Recruiting
Barcelona, Spain, 08036
Contact: Jose Brugada, MD +34932275703 jbrugada@clinic.ub.es
Principal Investigator: Jose Brugada, MD
Hospital Puerta de Hierro	Recruiting
Madrid, Spain
Contact: Ignacio Fernandez-Lozano, MD
Principal Investigator: Ignacio Fernandez-Lozano, MD
Hospital La Fe	Active, not recruiting
Valencia, Spain
Spain, Guipuzcoa
Hospital Donostia	Recruiting
Donostia, Guipuzcoa, Spain
Contact: Jose M Porres, MD
Principal Investigator: Jose M Porres, MD

Sponsors and Collaborators

Hospital Clinic of Barcelona

More Information

No publications provided

Responsible Party:	Hospital Clinic de Barcelona ( José Brugada )
Study ID Numbers:	AJUAR, EudraCT number:2007-006334-33
Study First Received:	June 19, 2008
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00702117 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Ajmaline
Heart Diseases
Genetic Diseases, Inborn
Tachycardia
Brugada Syndrome
Flecainide

Cardiovascular Agents
Anti-Arrhythmia Agents
Atrial Fibrillation
Tachycardia, Ventricular
Procainamide
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Heart Diseases
Disease
Tachycardia
Cardiovascular Agents
Pharmacologic Actions
Ajmaline
Pathologic Processes
Genetic Diseases, Inborn
Therapeutic Uses

Syndrome
Brugada Syndrome
Flecainide
Cardiovascular Diseases
Anti-Arrhythmia Agents
Atrial Fibrillation
Tachycardia, Ventricular
Procainamide
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 09, 2009