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Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia
This study is currently recruiting participants.
Study NCT00383799   Information provided by Hospital General Universitario Gregorio Marañon
First Received: October 3, 2006   No Changes Posted

October 3, 2006
October 3, 2006
September 2005
 
To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation
Same as current
No Changes Posted
  • To compare efficacy of both therapies in relation to episode termination
  • To compare the rate of total adverse events, cardiac and non cardiac, occurring during an observation period of 24 hours after treatment was applied
Same as current
 
Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia
Comparison of Intravenous Amiodarone Versus Intravenous Procainamide for the Acute Treatment of Regular and Haemodynamically Well Tolerated Wide QRS Tachycardia (Probably of Ventricular Origen). The PROCAMIO Multicenter Study

The purpose of this study is to determine whether intravenous amiodarone has less cardiac significant adverse events compared to intravenous procainamide in the acute treatment of haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably ventricular origen.

Multicenter, prospective and randomized study in phase IV. A total of 302 patients will be included in the study within 40-50 institutions in Spain. Patients with regular and monomorphic tachycardia ≥ 120 bpm, QRS ≥ 120 ms and haemodynamically well tolerated will be randomized to receive iv amiodarone (single dosage: 5 mg/kg in 20 minutes) vs iv procainamide (single dosage: 10 mg/kg in 20 minutes). The study period will be 40 minutes from infusion initiation. Study variables include the presence of clinically cardiac significant adverse events: hypotension, syncope, heart failure, symptomatic sinus bradycardia, AV block, proarrhythmia and tachycardia acceleration (<20 lpm)and death. Total observation period will be 24 hours after the end of the infusion.

Phase IV
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Ventricular Tachycardia
  • Wide QRS Tachycardia
Drug: iv Amiodarone and iv Procainamide
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
302
April 2008
 

Inclusion Criteria:

  • Patients with stable tachycardia ≥120 lpm, QRS ≥120 ms and haemodynamically well tolerated defined as: 1)Systolic blood pressure ≥90 mmHg, 2) absence of dyspnea at rest, 3)absence of peripheric hypoperfusion signs and 4)no severe angina.
  • Age > 18 years
  • Written inform consent obtained

Exclusion Criteria:

  • Treatment with iv amiodarone or iv procainamide during the previous 24 hours
  • QRS tachycardia <120 ms
  • Patients with QRS ≥120 ms tachycardia with haemodynamic compromise that requires urgent cardioversion for termination
  • Irregular tachycardia
  • Tachycardia that is considered as supraventricular due to physician criteria (adenosine and/or vagal manoeuvres response)
  • Patient that do not want to cooperate
Both
18 Years and older
No
Contact: Mercedes Ortiz, PhD 34607257825 merortiz@yahoo.es
Contact: Jesús Almendral, MD 34915868281 almendral@medifusion.com
Spain
 
NCT00383799
 
2005-001505-25
Hospital General Universitario Gregorio Marañon
 
Principal Investigator: Jesús Almendral, MD Hospital General Universitario Gregorio Marañón. Madrid. Spain
Study Director: Fernando Arribas, MD Hospital General Universitario 12 de Octubre. Madrid. Spain
Study Director: Rafael Peinado, MD Hospital General Universitario La Paz. Madrid. Spain
Study Director: Alfonso Martín, MD Hospital de Móstoles. Madrid. Spain
Study Director: Carmen del Arco, MD Hospital de la Princesa. Madrid. Spain
Study Director: Dolores Vigil, MD Hospital general Universitario Gregorio Marañón. Madrid. Spain
Study Director: Mercedes Ortiz, PhD Hospital General Universitario Gregorio Marañón. Madrid. Spain
Study Director: Blanca Coll-Vinent, MD Hospital Clinic. Barcelona. Spain
Hospital General Universitario Gregorio Marañon
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP