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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Hospital General Universitario Gregorio Marañon.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier:
NCT00383799
First received: October 3, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on September 18, 2014