Clinical trial NCT00383799: Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ventricular Tachycardia
Wide QRS Tachycardia
Keywords: Ventricular tachycardia
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2006-10-04
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation
timeFrame: 40 minutes
Secondary outcomes:
measure: To compare efficacy of both therapies in relation to episode termination
timeFrame: 40 minuutes
measure: To compare the rate of total adverse events, cardiac and non cardiac, occurring during an observation period of 24 hours after treatment was applied
timeFrame: 24 hours
Other outcomes:
Locations:
city: El Escorial
country: Spain
facility: Hospital El Escorial
state: Madrid
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Cartagena
country: Spain
facility: Hospital Santa María del Rosell
state: Murcia
city: Cieza
country: Spain
facility: Fundación Hospitalaria de Cieza
state: Murcia
city: San Javier
country: Spain
facility: Hospital Los Arcos
state: Murcia
city: Alicante
country: Spain
facility: Hospital General
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Granada
country: Spain
facility: Hospital San Cecilio
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Hospital de Móstoles
city: Madrid
country: Spain
facility: Hospital General Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Clínico Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: Hospital de Son Dureta
city: Palma de Mallorca
country: Spain
facility: Hospital de Son Llatzer
city: San Sebastián
country: Spain
facility: Hospital de Donostia
city: Sevilla
country: Spain
facility: Hospital de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hopital Clínico Universitario
city: Valladolid
country: Spain
facility: Hospital Río Hortega
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón. Madrid. Spain
name: Jesús Almendral, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario 12 de Octubre. Madrid. Spain
name: Fernando Arribas, MD
role: STUDY_DIRECTOR
affiliation: Hospital General Universitario La Paz. Madrid. Spain
name: Rafael Peinado, MD
role: STUDY_DIRECTOR
affiliation: Hospital de Móstoles. Madrid. Spain
name: Alfonso Martín, MD
role: STUDY_DIRECTOR
affiliation: Hospital de la Princesa. Madrid. Spain
name: Carmen del Arco, MD
role: STUDY_DIRECTOR
affiliation: Hospital general Universitario Gregorio Marañón. Madrid. Spain
name: Dolores Vigil, MD
role: STUDY_DIRECTOR
affiliation: Hospital General Universitario Gregorio Marañón. Madrid. Spain
name: Mercedes Ortiz, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Clinic. Barcelona. Spain
name: Blanca Coll-Vinent, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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. doi: 10.1161/CIRCULATIONAHA.105.166550. Epub 2005 Nov 28. No abstract available.
citation: 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. doi: 10.1161/CIRCULATIONAHA.106.178233. Epub 2006 Aug 25. No abstract available.