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

Condition(s) targeted: Ventricular Tachycardia; Wide QRS Tachycardia

Intervention: iv Amiodarone and iv Procainamide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hospital General Universitario Gregorio Marañon

Official(s) and/or principal investigator(s):
Jesús Almendral, MD, Principal Investigator, Affiliation: Hospital General Universitario Gregorio Marañón. Madrid. Spain
Fernando Arribas, MD, Study Director, Affiliation: Hospital General Universitario 12 de Octubre. Madrid. Spain
Rafael Peinado, MD, Study Director, Affiliation: Hospital General Universitario La Paz. Madrid. Spain
Alfonso Martín, MD, Study Director, Affiliation: Hospital de Móstoles. Madrid. Spain
Carmen del Arco, MD, Study Director, Affiliation: Hospital de la Princesa. Madrid. Spain
Dolores Vigil, MD, Study Director, Affiliation: Hospital general Universitario Gregorio Marañón. Madrid. Spain
Mercedes Ortiz, PhD, Study Director, Affiliation: Hospital General Universitario Gregorio Marañón. Madrid. Spain
Blanca Coll-Vinent, MD, Study Director, Affiliation: Hospital Clinic. Barcelona. Spain

Overall contact:
Mercedes Ortiz, PhD, Phone: 34607257825, Email: merortiz@yahoo.es

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.

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

Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Secondary outcome:

To compare efficacy of both therapies in relation to episode termination

To compare the rate of total adverse events, cardiac and non cardiac, occurring during an observation period of 24 hours after treatment was applied

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Mercedes Ortiz, PhD, Phone: 34607257825, Email: merortiz@yahoo.es

Hospital General Universitario Gregorio Marañón, Madrid 28007, Spain; Recruiting
Javier Muñoz, MD, Principal Investigator
Felipe Atienza, MD, Sub-Investigator
Jesus Almendral, MD, Principal Investigator

Hospital de Móstoles, Madrid, Spain; Recruiting
Alfonso Martín, MD, Principal Investigator

Hospital de La Princesa, Madrid, Spain; Recruiting
Carmen del Arco, MD, Principal Investigator

Hospital Puerta de Hierro, Madrid, Spain; Recruiting
Ignacio Fernández Lozano, MD, Sub-Investigator
Pedro Laguna, MD, Principal Investigator

Hospital Clínico San Carlos, Madrid, Spain; Recruiting
Julian Villacastín, MD, Principal Investigator
Raquel Lana, MD, Sub-Investigator

Hospital General Universitario La Paz, Madrid, Spain; Recruiting
Rafael Peinado, MD, Principal Investigator
Olga Madridano, MD, Sub-Investigator

Hospital Clinic, Barcelona, Spain; Recruiting
Blanca Coll-Vinent, MD, Principal Investigator
Luis Mont, MD, Sub-Investigator

Hospital Vall d'Hebron, Barcelona, Spain; Recruiting
Angel Moya, MD, Principal Investigator
Eva Ruiz, MD, Sub-Investigator

Hospital Virgen de la Arrixaca, Murcia, Spain; Recruiting
Arcadio García Alberola, MD, Principal Investigator
Luis Serrano, MD, Sub-Investigator

Hospital Carlos Haya, Malaga, Spain; Recruiting
Coral Suero, MD, Principal Investigator

Hospital Virgen de las Nieves, Granada, Spain; Recruiting
Miguel Alvarez, MD, Principal Investigator
Juan Sánchez, MD, Sub-Investigator

Hospital de Valme, Sevilla, Spain; Recruiting
Francisco Ruiz, MD, Principal Investigator

Hospital Virgen de la Salud, Toledo, Spain; Recruiting
Natividad Lain, MD, Principal Investigator
Eduardo Castellanos, MD, Sub-Investigator

Hospital Universitario Virgen del Rocío, Sevilla, Spain; Not yet recruiting
Alonso Pedrote, MD, Principal Investigator
Antonio Caballero, MD, Principal Investigator

Hospital Son Llatzer, Palma de Mallorca, Spain; Not yet recruiting
Jordi Tarradas, MD, Principal Investigator

Hospital Juan Canalejo, A Coruña, Spain; Not yet recruiting
Enrique Ricoy, MD, Principal Investigator
Luisa Pérez, MD, Sub-Investigator

Hospital Insular, Las Palmas, Spain; Not yet recruiting
Olga Medina, MD, Principal Investigator

Hopital Clínico Universitario, Valencia, Spain; Not yet recruiting
Jose Vicente Balaguer, MD, Principal Investigator

Hospital Universitario La Fe, Valencia, Spain; Not yet recruiting
Joaquin Osca, MD, Principal Investigator

Hospital 12 de Octubre, Madrid, Spain; Not yet recruiting
Rafael Salguero, MD, Principal Investigator

Hospital General, Alicante, Spain; Not yet recruiting
Jose Carbajosa, MD, Principal Investigator

Hospital Universitario de Getafe, Getafe, Madrid, Spain; Not yet recruiting
Agustín Pastor, MD, Principal Investigator

Hospital El Escorial, El Escorial, Madrid, Spain; Not yet recruiting
Pedro Gargantilla, MD, Principal Investigator

Fundación Hospitalaria de Cieza, Cieza, Murcia, Spain; Recruiting
Pascual Piñera, MD, Principal Investigator

Hospital Los Arcos, San Javier, Murcia, Spain; Not yet recruiting
Juan Vicente Ortega, MD, Principal Investigator

Hospital Santa María del Rosell, Cartagena, Murcia, Spain; Not yet recruiting
Francisco Javier Gil, MD, Principal Investigator

Protocol home's page

Related publications:

[No authors listed] ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death--Executive Summary: 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):1088-1132. Epub 2006 Aug 21. No abstract available.

[No authors listed] 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. No abstract available.

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. No abstract available.

Starting date: September 2005
Ending date: April 2008
Last updated: October 3, 2006