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Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias (AJUAR)

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ClinicalTrials.gov Identifier: NCT00702117
Recruitment Status : Completed
First Posted : June 20, 2008
Last Update Posted : December 15, 2010
Sponsor:
Information provided by:
Hospital Clinic of Barcelona

Brief 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


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Tachycardia, Ventricular Brugada Syndrome Drug: flecainide Drug: ajmaline Drug: procainamide Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias
Study Start Date : June 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Proportion of patients with reversion of atrial fibrillation [ Time Frame: 1 hour ]
  2. Proportion of patients with reversion of ventricular tachycardia [ Time Frame: 15 min ]
  3. Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test. [ Time Frame: 1 hour ]


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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: December 15, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Brugada Syndrome
Atrial Fibrillation
Tachycardia
Arrhythmias, Cardiac
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Genetic Diseases, Inborn
Flecainide
Ajmaline
Lorajmine
Procainamide
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action