Status:
TERMINATED
Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia
Lead Sponsor:
Hospital General Universitario Gregorio Marañon
Conditions:
Ventricular Tachycardia
Wide QRS Tachycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 wel...
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 ≥...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT00383799
Start Date
September 1 2005
End Date
June 1 2011
Last Update
April 6 2016
Active Locations (29)
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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