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Sponsors and Collaborators: |
Hospital General Universitario Gregorio Marañon Fundacion Investigacion Biomedica del Hospital Gregorio Marañon |
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Information provided by: | Hospital General Universitario Gregorio Marañon |
ClinicalTrials.gov Identifier: | NCT00383799 |
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 |
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Ventricular Tachycardia Wide QRS Tachycardia |
Drug: iv Amiodarone and iv Procainamide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 302 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | April 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mercedes Ortiz, PhD | 34607257825 | merortiz@yahoo.es |
Contact: Jesús Almendral, MD | 34915868281 | almendral@medifusion.com |
Spain | |
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 de Móstoles | Recruiting |
Madrid, Spain | |
Principal Investigator: Alfonso Martín, MD | |
Hospital de La Princesa | Recruiting |
Madrid, Spain | |
Principal Investigator: Carmen del Arco, MD | |
Hospital Puerta de Hierro | Recruiting |
Madrid, Spain | |
Sub-Investigator: Ignacio Fernández Lozano, MD | |
Principal Investigator: Pedro Laguna, MD | |
Hospital Clínico San Carlos | Recruiting |
Madrid, Spain | |
Principal Investigator: Julian Villacastín, MD | |
Sub-Investigator: Raquel Lana, MD | |
Hospital General Universitario La Paz | Recruiting |
Madrid, Spain | |
Principal Investigator: Rafael Peinado, MD | |
Sub-Investigator: Olga Madridano, MD | |
Hospital Virgen de la Salud | Recruiting |
Toledo, Spain | |
Principal Investigator: Natividad Lain, MD | |
Sub-Investigator: Eduardo Castellanos, MD | |
Hospital Vall d'Hebron | Recruiting |
Barcelona, Spain | |
Principal Investigator: Angel Moya, MD | |
Sub-Investigator: Eva Ruiz, MD | |
Hospital Virgen de la Arrixaca | Recruiting |
Murcia, Spain | |
Principal Investigator: Arcadio García Alberola, MD | |
Sub-Investigator: Luis Serrano, MD | |
Hospital Carlos Haya | Recruiting |
Malaga, Spain | |
Principal Investigator: Coral Suero, MD | |
Hospital Virgen de las Nieves | Recruiting |
Granada, Spain | |
Principal Investigator: Miguel Alvarez, MD | |
Sub-Investigator: Juan Sánchez, MD | |
Hospital de Valme | Recruiting |
Sevilla, Spain | |
Principal Investigator: Francisco Ruiz, MD | |
Hospital Clinic | Recruiting |
Barcelona, Spain | |
Principal Investigator: Blanca Coll-Vinent, MD | |
Sub-Investigator: Luis Mont, MD | |
Hospital Universitario Virgen del Rocío | Not yet recruiting |
Sevilla, Spain | |
Principal Investigator: Alonso Pedrote, MD | |
Principal Investigator: Antonio Caballero, MD | |
Hospital Son Llatzer | Not yet recruiting |
Palma de Mallorca, Spain | |
Principal Investigator: Jordi Tarradas, MD | |
Hospital Juan Canalejo | Not yet recruiting |
A Coruña, Spain | |
Principal Investigator: Enrique Ricoy, MD | |
Sub-Investigator: Luisa Pérez, MD | |
Hospital Insular | Not yet recruiting |
Las Palmas, Spain | |
Principal Investigator: Olga Medina, MD | |
Hospital 12 de Octubre | Not yet recruiting |
Madrid, Spain | |
Principal Investigator: Rafael Salguero, MD | |
Hospital Universitario La Fe | Not yet recruiting |
Valencia, Spain | |
Principal Investigator: Joaquin Osca, MD | |
Hopital Clínico Universitario | Not yet recruiting |
Valencia, Spain | |
Principal Investigator: Jose Vicente Balaguer, MD | |
Hospital General | Not yet recruiting |
Alicante, Spain | |
Principal Investigator: Jose Carbajosa, MD | |
Spain, Madrid | |
Hospital Universitario de Getafe | Not yet recruiting |
Getafe, Madrid, Spain | |
Principal Investigator: Agustín Pastor, MD | |
Hospital El Escorial | Not yet recruiting |
El Escorial, Madrid, Spain | |
Principal Investigator: Pedro Gargantilla, MD | |
Spain, Murcia | |
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 Santa María del Rosell | Not yet recruiting |
Cartagena, Murcia, Spain | |
Principal Investigator: Francisco Javier Gil, MD |
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 |
Study ID Numbers: | 2005-001505-25 |
Study First Received: | October 3, 2006 |
Last Updated: | October 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00383799 |
Health Authority: | Spain: Spanish Agency of Medicines; Spain: Comité Ético de Investigación Clínica |
Ventricular tachycardia |
Heart Diseases Tachycardia Tachycardia, Ventricular |
Procainamide Amiodarone Arrhythmias, Cardiac |
Vasodilator Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Cardiovascular Diseases Cardiovascular Agents Anti-Arrhythmia Agents Pharmacologic Actions |