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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2011

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.

Interventions

  • Drug: iv Amiodarone
  • Drug: iv Procainamide

Arms, Groups and Cohorts

  • Active Comparator: Group 1
    • IV procainamide (single dose: 10 mg/kg over 20 min)
  • Active Comparator: Group 2
    • IV Amiodarone (single dose: 5 mg/kg over 20 min)

Clinical Trial Outcome Measures

Primary Measures

  • To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation
    • Time Frame: 40 minutes

Secondary Measures

  • To compare efficacy of both therapies in relation to episode termination
    • Time Frame: 40 minuutes
  • 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

Participating 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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital General Universitario Gregorio Marañon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jesús Almendral, MD, Principal Investigator, Hospital General Universitario Gregorio Marañón. Madrid. Spain
    • Fernando Arribas, MD, Study Director, Hospital General Universitario 12 de Octubre. Madrid. Spain
    • Rafael Peinado, MD, Study Director, Hospital General Universitario La Paz. Madrid. Spain
    • Alfonso Martín, MD, Study Director, Hospital de Móstoles. Madrid. Spain
    • Carmen del Arco, MD, Study Director, Hospital de la Princesa. Madrid. Spain
    • Dolores Vigil, MD, Study Director, Hospital general Universitario Gregorio Marañón. Madrid. Spain
    • Mercedes Ortiz, PhD, Study Director, Hospital General Universitario Gregorio Marañón. Madrid. Spain
    • Blanca Coll-Vinent, MD, Study Director, Hospital Clinic. Barcelona. Spain

References

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.

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.

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.

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