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

Primary Purpose

Atrial Fibrillation, Tachycardia, Ventricular, Brugada Syndrome

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
flecainide
ajmaline
procainamide
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Donostia
  • Servicio de Cardiología, Hospital Clínic
  • Hospital Puerta de Hierro
  • Hospital La Fe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

A

B

c

d

e

f

Arm Description

IV flecainide in atrial fibrillation

IV ajmaline in atrial fibrillation

iv procainamide in ventricular tachycardia

iv ajmaline in ventricular tachycardia

iv flecainide in diagnosis of Brugada Sd

iv ajmaline in diagnosis of Brugada Sd

Outcomes

Primary Outcome Measures

Proportion of patients with reversion of atrial fibrillation
Proportion of patients with reversion of ventricular tachycardia
Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2008
Last Updated
December 14, 2010
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT00702117
Brief Title
Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias
Acronym
AJUAR
Official Title
Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 : 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Tachycardia, Ventricular, Brugada Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
IV flecainide in atrial fibrillation
Arm Title
B
Arm Type
Experimental
Arm Description
IV ajmaline in atrial fibrillation
Arm Title
c
Arm Type
Active Comparator
Arm Description
iv procainamide in ventricular tachycardia
Arm Title
d
Arm Type
Experimental
Arm Description
iv ajmaline in ventricular tachycardia
Arm Title
e
Arm Type
Active Comparator
Arm Description
iv flecainide in diagnosis of Brugada Sd
Arm Title
f
Arm Type
Experimental
Arm Description
iv ajmaline in diagnosis of Brugada Sd
Intervention Type
Drug
Intervention Name(s)
flecainide
Intervention Description
2 mg/kg iv in 10 minutes
Intervention Type
Drug
Intervention Name(s)
ajmaline
Intervention Description
1 mg/kg iv in 10 minutes
Intervention Type
Drug
Intervention Name(s)
procainamide
Intervention Description
10 mg/kg iv in 10 minutes
Primary Outcome Measure Information:
Title
Proportion of patients with reversion of atrial fibrillation
Time Frame
1 hour
Title
Proportion of patients with reversion of ventricular tachycardia
Time Frame
15 min
Title
Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital Donostia
City
Donostia
State/Province
Guipuzcoa
Country
Spain
Facility Name
Servicio de Cardiología, Hospital Clínic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

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Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

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