Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia
Information source: Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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 MartÃn, 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
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.
Clinical Details
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 terminationTo 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.
Eligibility
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
Locations and Contacts
Mercedes Ortiz, PhD, Phone: 34607257825, Email: merortiz@yahoo.es
Hospital Juan Canalejo, A Coruña, Spain; Not yet recruiting Enrique Ricoy, MD, Principal Investigator Luisa Pérez, MD, Sub-Investigator
Hospital General, Alicante, Spain; Not yet recruiting Jose Carbajosa, MD, Principal 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 las Nieves, Granada, Spain; Recruiting Miguel Alvarez, MD, Principal Investigator Juan Sánchez, MD, Sub-Investigator
Hospital Insular, Las Palmas, Spain; Not yet recruiting Olga Medina, MD, Principal Investigator
Hospital 12 de Octubre, Madrid, Spain; Not yet recruiting Rafael Salguero, MD, Principal Investigator
Hospital ClÃnico San Carlos, Madrid, Spain; Recruiting Julian VillacastÃn, MD, Principal Investigator Raquel Lana, MD, Sub-Investigator
Hospital de La Princesa, Madrid, Spain; Recruiting Carmen del Arco, MD, Principal Investigator
Hospital de Móstoles, Madrid, Spain; Recruiting Alfonso MartÃn, MD, Principal Investigator
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 General Universitario La Paz, Madrid, Spain; Recruiting Rafael Peinado, MD, Principal Investigator Olga Madridano, MD, Sub-Investigator
Hospital Puerta de Hierro, Madrid, Spain; Recruiting Ignacio Fernández Lozano, MD, Sub-Investigator Pedro Laguna, MD, Principal Investigator
Hospital Carlos Haya, Malaga, Spain; Recruiting Coral Suero, MD, Principal Investigator
Hospital Virgen de la Arrixaca, Murcia, Spain; Recruiting Arcadio GarcÃa Alberola, MD, Principal Investigator Luis Serrano, MD, Sub-Investigator
Hospital Son Llatzer, Palma de Mallorca, Spain; Not yet recruiting Jordi Tarradas, MD, Principal Investigator
Hospital de Valme, Sevilla, Spain; Recruiting Francisco Ruiz, MD, Principal Investigator
Hospital Universitario Virgen del RocÃo, Sevilla, Spain; Not yet recruiting Alonso Pedrote, MD, Principal Investigator Antonio Caballero, MD, Principal Investigator
Hospital Virgen de la Salud, Toledo, Spain; Recruiting Natividad Lain, MD, Principal Investigator Eduardo Castellanos, MD, Sub-Investigator
Hopital ClÃnico 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 El Escorial, El Escorial, Madrid, Spain; Not yet recruiting Pedro Gargantilla, MD, Principal Investigator
Hospital Universitario de Getafe, Getafe, Madrid, Spain; Not yet recruiting AgustÃn Pastor, MD, Principal Investigator
Hospital Santa MarÃa del Rosell, Cartagena, Murcia, Spain; Not yet recruiting Francisco Javier Gil, 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
Additional Information
Related publications: 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. 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.
Starting date: September 2005
Last updated: October 3, 2006
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