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

Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00383799
• Other study ID #: 2005-001505-25
• Status: Terminated
• Phase: Phase 4
• First received: October 3, 2006
• Last updated: April 4, 2016
• Start date: September 2005
• Est. completion date: June 2011

Study information

• Verified date: March 2016
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 302
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia
• Wide QRS Tachycardia

Intervention

Drug:
• iv Amiodarone

• iv Procainamide

Locations

Country	Name	City	State
Spain	Hospital General	Alicante
Spain	Hospital Clinic	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Santa María del Rosell	Cartagena	Murcia
Spain	Fundación Hospitalaria de Cieza	Cieza	Murcia
Spain	Hospital El Escorial	El Escorial	Madrid
Spain	Hospital Universitario de Getafe	Getafe	Madrid
Spain	Hospital San Cecilio	Granada
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 Gregorio Marañón	Madrid
Spain	Hospital General Universitario La Paz	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Carlos Haya	Malaga
Spain	Hospital Clínico Virgen de la Victoria	Málaga
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 Los Arcos	San Javier	Murcia
Spain	Hospital de Donostia	San Sebastián
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 Río Hortega	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

References & Publications (3)

ECC Committee, Subcommittees and Task Forces of the American Heart Association. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2005 Dec 13;112(24 Suppl):IV1-203. Epub 2005 Nov 28. — View Citation

Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Part 6: advanced cardiovascular life support: section 5: pharmacology I: agents for arrhythmias. The American Heart Association in collaboration with the International Liaison Committee on Resuscitation. Circulation. 2000 Aug 22;102(8 Suppl):I112-28. — View Citation

Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B, Blanc JJ, Budaj A, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (writing committee to develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Sep 5;114(10):e385-484. Epub 2006 Aug 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation		40 minutes	Yes
Secondary	To compare efficacy of both therapies in relation to episode termination		40 minuutes	No
Secondary	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	Yes