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

Phase 4

Terminated

• Conditions: Ventricular Tachycardia; Wide QRS Tachycardia
• Interventions: Drug: iv Procainamide; Drug: iv Amiodarone

• Registration Number: NCT00383799
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

Brief Summary

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

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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-03
• Study First Posted: 2006-10-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 302

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	iv Procainamide	IV procainamide (single dose: 10 mg/kg over 20 min)
Group 2	iv Amiodarone	IV Amiodarone (single dose: 5 mg/kg over 20 min)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (29)

Hospital El Escorial; 🇪🇸 El Escorial, Madrid, Spain

Hospital Universitario de Getafe; 🇪🇸 Getafe, Madrid, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Hospital General; 🇪🇸 Alicante, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital San Cecilio; 🇪🇸 Granada, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital de La Princesa; 🇪🇸 Madrid, Spain

Hospital de Móstoles; 🇪🇸 Madrid, Spain

Hospital General Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Carlos Haya; 🇪🇸 Malaga, Spain

Hospital Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital de Son Dureta; 🇪🇸 Palma de Mallorca, Spain

Hospital de Son Llatzer; 🇪🇸 Palma de Mallorca, Spain

Hospital Clínico Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital de Donostia; 🇪🇸 San Sebastián, Spain

Hospital Río Hortega; 🇪🇸 Valladolid, Spain

Hospital de Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hopital Clínico Universitario; 🇪🇸 Valencia, Spain

Hospital Los Arcos; 🇪🇸 San Javier, Murcia, Spain

Hospital Santa María del Rosell; 🇪🇸 Cartagena, Murcia, Spain

Fundación Hospitalaria de Cieza; 🇪🇸 Cieza, Murcia, Spain