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OpenTrials
Completed

NCT Number: NCT00702117

Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brugada Syndrome Cardiac Conduction System Disease Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Servicio de Cardiología, Hospital Clínic, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flecainide

Drug

2 mg/kg iv in 10 minutes

ajmaline

Drug

1 mg/kg iv in 10 minutes

procainamide

Drug

10 mg/kg iv in 10 minutes

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Acronym: AJUAR

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 20, 2008
Registry last updated
Dec 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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