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

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ClinicalTrials.gov Identifier: NCT00383799
Recruitment Status : Terminated (Steering Committee decision after inclusion of 74 patients after 6 years and very slow inclusion rate)
First Posted : October 4, 2006
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital General Universitario Gregorio Marañon

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Wide QRS Tachycardia Drug: iv Amiodarone Drug: iv Procainamide Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2005
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1
IV procainamide (single dose: 10 mg/kg over 20 min)
 Drug: iv Procainamide
Active Comparator: Group 2
IV Amiodarone (single dose: 5 mg/kg over 20 min)
 Drug: iv Amiodarone


Outcome Measures
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Primary Outcome Measures :
  1. To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation [ Time Frame: 40 minutes ]

Secondary Outcome Measures :
  1. To compare efficacy of both therapies in relation to episode termination [ Time Frame: 40 minuutes ]
  2. To compare the rate of total adverse events, cardiac and non cardiac, occurring during an observation period of 24 hours after treatment was applied [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383799


Locations
Spain
Hospital El Escorial
El Escorial, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Santa María del Rosell
Cartagena, Murcia, Spain
Fundación Hospitalaria de Cieza
Cieza, Murcia, Spain
Hospital Los Arcos
San Javier, Murcia, Spain
Hospital General
Alicante, Spain
Hospital Clinic
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital de Basurto
Bilbao, Spain
Hospital San Cecilio
Granada, Spain
Hospital Virgen de las Nieves
Granada, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital de La Princesa
Madrid, Spain
Hospital de Móstoles
Madrid, Spain
Hospital General Universitario La Paz
Madrid, Spain
Hospital Puerta de Hierro
Madrid, Spain
Hospital Carlos Haya
Malaga, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital Clínico Virgen de la Victoria
Málaga, Spain
Hospital de Son Dureta
Palma de Mallorca, Spain
Hospital de Son Llatzer
Palma de Mallorca, Spain
Hospital de Donostia
San Sebastián, Spain
Hospital de Valme
Sevilla, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Hospital Virgen de la Salud
Toledo, Spain
Hopital Clínico Universitario
Valencia, Spain
Hospital Río Hortega
Valladolid, Spain
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B, Blanc JJ, Budaj A, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: 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):e385-484. Epub 2006 Aug 25.

Responsible Party: Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT00383799     History of Changes
Other Study ID Numbers: 2005-001505-25
First Posted: October 4, 2006    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: March 2016

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
Vasodilator Agents
Potassium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Voltage-Gated Sodium Channel Blockers