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

Hospital General Universitario Gregorio Marañon

Status and phase: Terminated; Phase 4

Conditions: Wide QRS Tachycardia; Ventricular Tachycardia

Treatments: Drug: iv Procainamide; Drug: iv Amiodarone

Study type: Interventional

Funder types: Other

Identifiers

NCT00383799

2005-001505-25

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 302 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

Group 1

Active Comparator group

Description:

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

Treatment:

Drug: iv Procainamide

Group 2

Active Comparator group

Description:

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

Treatment:

Drug: iv Amiodarone