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

NCT00383799 | Terminated Phase 4 DMC

• 1 other identifier: 2005-001505-25
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 29

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.

Conditions

Ventricular Tachycardia; Wide QRS Tachycardia

Keywords

Ventricular tachycardia

Outcome Measures

Primary Outcomes (1)

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

  40 minutes

Secondary Outcomes (2)

• To compare efficacy of both therapies in relation to episode termination

  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

  24 hours

Study Arms (2)

Group 1

ACTIVE COMPARATOR

IV procainamide (single dose: 10 mg/kg over 20 min)

Drug: iv Procainamide

Group 2

ACTIVE COMPARATOR

IV Amiodarone (single dose: 5 mg/kg over 20 min)

Drug: iv Amiodarone

Interventions

iv Amiodarone DRUG

Group 2

iv Procainamide DRUG

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (29)

Hospital El Escorial

El Escorial, Madrid, Spain

Location

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Location

Hospital Santa María del Rosell

Cartagena, Murcia, Spain

Location

Fundación Hospitalaria de Cieza

Cieza, Murcia, Spain

Location

Hospital Los Arcos

San Javier, Murcia, Spain

Location

Hospital General

Alicante, Spain

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital de Basurto

Bilbao, Spain

Location

Hospital San Cecilio

Granada, Spain

Location

Hospital Virgen de las Nieves

Granada, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital de La Princesa

Madrid, Spain

Location

Hospital de Móstoles

Madrid, Spain

Location

Hospital General Universitario La Paz

Madrid, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

Hospital Carlos Haya

Málaga, Spain

Location

Hospital Clínico Virgen de la Victoria

Málaga, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Hospital de Son Dureta

Palma de Mallorca, Spain

Location

Hospital de Son Llatzer

Palma de Mallorca, Spain

Location

Hospital de Donostia

San Sebastián, Spain

Location

Hospital de Valme

Seville, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Virgen de la Salud

Toledo, Spain

Location

Hopital Clínico Universitario

Valencia, Spain

Location

Hospital Río Hortega

Valladolid, Spain

Location

Related Publications (3)

• 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.

  PMID: 10966669 BACKGROUND

• 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.

  PMID: 16314375 BACKGROUND

• 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.

  PMID: 16935995 BACKGROUND

Related Links

• Protocol home's page

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Amiodarone; Procainamide

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jesús Almendral, MD

  Hospital General Universitario Gregorio Marañón. Madrid. Spain

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2006
• First Posted: October 4, 2006
• Study Start: September 1, 2005
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 6, 2016

Record last verified: 2016-03

Locations

ES (29)