Ventricular Tachycardia | Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia
Ventricular Tachycardia research study
What is the primary objective of this 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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Wide QRS Tachycardia
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Group 1IV procainamide (single dose: 10 mg/kg over 20 min)
Group 2IV Amiodarone (single dose: 5 mg/kg over 20 min)
Start Date: September 2005
Completed Date: June 2011
Phase: Phase 4
Primary Outcome: To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation
Secondary Outcome: To compare efficacy of both therapies in relation to episode termination
Study sponsors, principal investigator, and references
Principal Investigator: Jesús Almendral, MD
Lead Sponsor: Hospital General Universitario Gregorio Marañon
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.