Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias (AJUAR)
This study has been completed.
Sponsor:
Hospital Clinic of Barcelona
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
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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 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:
Genetics Home Reference related topics:
Brugada syndrome
catecholaminergic polymorphic ventricular tachycardia
familial atrial fibrillation
Drug Information available for:
Procainamide
Procainamide hydrochloride
Flecainide
Flecainide acetate
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 May 19, 2013