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

Phase 4TerminatedNCT00383799

Hospital General Universitario Gregorio Marañon302 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

302

Conditions

Ventricular Tachycardia Wide QRS Tachycardia

Interventions

iv AmiodaroneDRUG

iv ProcainamideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (29)

Hospital El Escorial

El Escorial, Madrid, Spain

Outcomes

Primary Outcomes

To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation

Time frame: 40 minutes

Secondary Outcomes

To compare efficacy of both therapies in relation to episode termination

Time frame: 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

Time frame: 24 hours

Data from ClinicalTrials.gov

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