Ventricular Tachycardia, Wide QRS Tachycardia
Conditions
Keywords
Ventricular tachycardia
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.
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.
Interventions
DRUGiv Amiodarone
DRUGiv Procainamide
Sponsors
Hospital General Universitario Gregorio Marañon
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation | 40 minutes |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Spain
Outcome results
None listed