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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2011-06-30

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.

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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.

Conditions

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Ventricular Tachycardia Wide QRS Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type ACTIVE_COMPARATOR

iv Procainamide

Intervention Type DRUG

Group 2

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

Group Type ACTIVE_COMPARATOR

iv Amiodarone

Intervention Type DRUG

Interventions

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iv Amiodarone

Intervention Type DRUG

iv Procainamide

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No