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

April 4, 2016 updated by: Hospital General Universitario Gregorio Marañon

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Hospital General
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Clínic
      • Bilbao, Spain
        • Hospital de Basurto
      • Granada, Spain
        • Hospital San Cecilio
      • Granada, Spain
        • Hospital Virgen de las Nieves
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital De Mostoles
      • Madrid, Spain
        • Hospital General Universitario La Paz
      • Madrid, Spain
        • Hospital de La Princesa
      • Madrid, Spain
        • Hospital Puerta de Hierro
      • Malaga, Spain
        • Hospital Carlos Haya
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Málaga, Spain
        • Hospital Clínico Virgen de la Victoria
      • Palma de Mallorca, Spain
        • Hospital de Son Dureta
      • Palma de Mallorca, Spain
        • Hospital de Son Llàtzer
      • San Sebastián, Spain
        • Hospital de Donostia
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocío
      • Sevilla, Spain
        • Hospital De Valme
      • Toledo, Spain
        • Hospital Virgen De La Salud
      • Valencia, Spain
        • Hopital Clínico Universitario
      • Valladolid, Spain
        • Hospital Rio Hortega
    • Madrid
      • El Escorial, Madrid, Spain
        • Hospital El Escorial
      • Getafe, Madrid, Spain
        • Hospital Universitario de Getafe
    • Murcia
      • Cartagena, Murcia, Spain
        • Hospital Santa Maria del Rosell
      • Cieza, Murcia, Spain
        • Fundación Hospitalaria de Cieza
      • San Javier, Murcia, Spain
        • Hospital Los Arcos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare efficacy of both therapies in relation to episode termination
Time Frame: 40 minuutes
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Investigators

  • Principal Investigator: Jesús Almendral, MD, Hospital General Universitario Gregorio Marañon. 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 Marañon. Madrid. Spain
  • Study Director: Mercedes Ortiz, PhD, Hospital General Universitario Gregorio Marañon. Madrid. Spain
  • Study Director: Blanca Coll-Vinent, MD, Hospital Clinic. Barcelona. Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 3, 2006

First Submitted That Met QC Criteria

October 3, 2006

First Posted (Estimate)

October 4, 2006

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-001505-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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