Trial | NCT00383799  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    302
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.
Study Started
Sep 30
2005
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Apr 06
2016
Estimate

Drug iv Amiodarone

Drug iv Procainamide

Group 1 Active Comparator

IV procainamide (single dose: 10 mg/kg over 20 min)

Group 2 Active Comparator

IV Amiodarone (single dose: 5 mg/kg over 20 min)

Criteria 

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
No Results Posted