Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia - Full Text View

Sponsor:	Hospital General Universitario Gregorio Marañon
Information provided by:	Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:	NCT00383799

Purpose

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.

Condition	Intervention	Phase
Ventricular Tachycardia Wide QRS Tachycardia	Drug: iv Amiodarone and iv Procainamide	Phase IV

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome catecholaminergic polymorphic ventricular tachycardia short QT syndrome

Drug Information available for: Procainamide Amiodarone hydrochloride Amidox Procainamide hydrochloride Amiodarone

U.S. FDA Resources

Further study details as provided by Hospital General Universitario Gregorio Marañon:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	302
Study Start Date:	September 2005
Estimated Study Completion Date:	April 2008

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383799

Contacts

Contact: Mercedes Ortiz, PhD	34607257825	merortiz@yahoo.es
Contact: Jesús Almendral, MD	34915868281	almendral@medifusion.com

Locations

Spain
Hospital El Escorial	Not yet recruiting
El Escorial, Madrid, Spain
Principal Investigator: Pedro Gargantilla, MD
Hospital Universitario de Getafe	Not yet recruiting
Getafe, Madrid, Spain
Principal Investigator: Agustín Pastor, MD
Hospital Santa María del Rosell	Not yet recruiting
Cartagena, Murcia, Spain
Principal Investigator: Francisco Javier Gil, MD
Fundación Hospitalaria de Cieza	Recruiting
Cieza, Murcia, Spain
Principal Investigator: Pascual Piñera, MD
Hospital Los Arcos	Not yet recruiting
San Javier, Murcia, Spain
Principal Investigator: Juan Vicente Ortega, MD
Hospital Juan Canalejo	Not yet recruiting
A Coruña, Spain
Principal Investigator: Enrique Ricoy, MD
Sub-Investigator: Luisa Pérez, MD
Hospital General	Not yet recruiting
Alicante, Spain
Principal Investigator: Jose Carbajosa, MD
Hospital Clinic	Recruiting
Barcelona, Spain
Principal Investigator: Blanca Coll-Vinent, MD
Sub-Investigator: Luis Mont, MD
Hospital Vall d'Hebron	Recruiting
Barcelona, Spain
Principal Investigator: Angel Moya, MD
Sub-Investigator: Eva Ruiz, MD
Hospital Virgen de las Nieves	Recruiting
Granada, Spain
Principal Investigator: Miguel Alvarez, MD
Sub-Investigator: Juan Sánchez, MD
Hospital Insular	Not yet recruiting
Las Palmas, Spain
Principal Investigator: Olga Medina, MD
Hospital General Universitario La Paz	Recruiting
Madrid, Spain
Principal Investigator: Rafael Peinado, MD
Sub-Investigator: Olga Madridano, MD
Hospital Clínico San Carlos	Recruiting
Madrid, Spain
Principal Investigator: Julian Villacastín, MD
Sub-Investigator: Raquel Lana, MD
Hospital Puerta de Hierro	Recruiting
Madrid, Spain
Sub-Investigator: Ignacio Fernández Lozano, MD
Principal Investigator: Pedro Laguna, MD
Hospital de La Princesa	Recruiting
Madrid, Spain
Principal Investigator: Carmen del Arco, MD
Hospital de Móstoles	Recruiting
Madrid, Spain
Principal Investigator: Alfonso Martín, MD
Hospital 12 de Octubre	Not yet recruiting
Madrid, Spain
Principal Investigator: Rafael Salguero, MD
Hospital General Universitario Gregorio Marañón	Recruiting
Madrid, Spain, 28007
Principal Investigator: Javier Muñoz, MD
Sub-Investigator: Felipe Atienza, MD
Principal Investigator: Jesus Almendral, MD
Hospital Carlos Haya	Recruiting
Malaga, Spain
Principal Investigator: Coral Suero, MD
Hospital Virgen de la Arrixaca	Recruiting
Murcia, Spain
Principal Investigator: Arcadio García Alberola, MD
Sub-Investigator: Luis Serrano, MD
Hospital Son Llatzer	Not yet recruiting
Palma de Mallorca, Spain
Principal Investigator: Jordi Tarradas, MD
Hospital de Valme	Recruiting
Sevilla, Spain
Principal Investigator: Francisco Ruiz, MD
Hospital Universitario Virgen del Rocío	Not yet recruiting
Sevilla, Spain
Principal Investigator: Alonso Pedrote, MD
Principal Investigator: Antonio Caballero, MD
Hospital Virgen de la Salud	Recruiting
Toledo, Spain
Principal Investigator: Natividad Lain, MD
Sub-Investigator: Eduardo Castellanos, MD
Hopital Clínico Universitario	Not yet recruiting
Valencia, Spain
Principal Investigator: Jose Vicente Balaguer, MD
Hospital Universitario La Fe	Not yet recruiting
Valencia, Spain
Principal Investigator: Joaquin Osca, MD

Sponsors and Collaborators

Hospital General Universitario Gregorio Marañon

Investigators

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

More Information

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.

ClinicalTrials.gov Identifier:	NCT00383799 History of Changes
Other Study ID Numbers:	2005-001505-25
Study First Received:	October 3, 2006
Last Updated:	October 3, 2006
Health Authority:	Spain: Spanish Agency of Medicines; Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital General Universitario Gregorio Marañon:

Ventricular tachycardia

Additional relevant MeSH terms:

Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Procainamide

Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on February 12, 2012