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...
Date First Received: October 3, 2006
Last Updated: October 3, 2006
Verified by: Hospital General Universitario Gregorio Marañon, October 2006
Clinical Trial Phase: Phase 4 | Start Date: September 2005
Overall Status: Recruiting
Estimated Enrollment: 302
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: iv Amiodarone and iv Procainamide
Outcome Measures for this Clinical Trial
Primary Measures
- To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation
Secondary 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Hospital General Universitario Gregorio Marañon
Overall Clinical Trial Officials and Contacts
Jesús Almendral, MD Principal Investigator Hospital General Universitario Gregorio Marañón. Madrid. Spain
Overall Contact: Mercedes Ortiz, PhD 34607257825 merortiz@yahoo.es
Related Publications
References
[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.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00383799
Study ID Number: 2005-001505-25
ClinicalTrials.gov Identifier: NCT00383799
Health Authority: Spain: Spanish Agency of Medicines
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
