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

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00702117
First received: June 19, 2008
Last updated: December 14, 2010
Last verified: January 2010
  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 :

  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 Intervention Phase
Atrial Fibrillation
Tachycardia, Ventricular
Brugada Syndrome
Drug: flecainide
Drug: ajmaline
Drug: procainamide
Phase 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014