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

Sponsor

Hospital General Universitario Gregorio Marañon (Other)

Overall Status

Terminated

CT.gov ID

NCT00383799

Collaborator

(none)

302

Enrollment

Locations

Arms

Duration (Months)

10.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Sep 1, 2005

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

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

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

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital El Escorial	El Escorial	Madrid	Spain
2	Hospital Universitario de Getafe	Getafe	Madrid	Spain
3	Hospital Santa María del Rosell	Cartagena	Murcia	Spain
4	Fundación Hospitalaria de Cieza	Cieza	Murcia	Spain
5	Hospital Los Arcos	San Javier	Murcia	Spain
6	Hospital General	Alicante		Spain
7	Hospital Clinic	Barcelona		Spain
8	Hospital Vall d'Hebron	Barcelona		Spain
9	Hospital de Basurto	Bilbao		Spain
10	Hospital San Cecilio	Granada		Spain
11	Hospital Virgen de las Nieves	Granada		Spain
12	Hospital General Universitario Gregorio Marañón	Madrid		Spain	28007
13	Hospital 12 de Octubre	Madrid		Spain
14	Hospital Clínico San Carlos	Madrid		Spain
15	Hospital de La Princesa	Madrid		Spain
16	Hospital de Móstoles	Madrid		Spain
17	Hospital General Universitario La Paz	Madrid		Spain
18	Hospital Puerta de Hierro	Madrid		Spain
19	Hospital Carlos Haya	Malaga		Spain
20	Hospital Virgen de la Arrixaca	Murcia		Spain
21	Hospital Clínico Virgen de la Victoria	Málaga		Spain
22	Hospital de Son Dureta	Palma de Mallorca		Spain
23	Hospital de Son Llatzer	Palma de Mallorca		Spain
24	Hospital de Donostia	San Sebastián		Spain
25	Hospital de Valme	Sevilla		Spain
26	Hospital Universitario Virgen del Rocío	Sevilla		Spain
27	Hospital Virgen de la Salud	Toledo		Spain
28	Hopital Clínico Universitario	Valencia		Spain
29	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