Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Ventricular Tachycardia, Wide QRS Tachycardia

Intervention / Treatment
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* Drug: iv Amiodarone
* Drug: iv Procainamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>IV procainamide (single dose: 10 mg/kg over 20 min) | Drug: iv Procainamide<br> <br> |
| Active Comparator: Group 2<br>IV Amiodarone (single dose: 5 mg/kg over 20 min) | Drug: iv Amiodarone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation |  | 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare efficacy of both therapies in relation to episode termination |  | 40 minuutes | 
| To compare the rate of total adverse events, cardiac and non cardiac, occurring during an observation period of 24 hours after treatment was applied |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular tachycardia