A Phase 4 interventional study of iv Amiodarone and iv Procainamide in Ventricular Tachycardia and Wide QRS Tachycardia, sponsored by Hospital General Universitario Gregorio Marañon. Terminated at 29 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-06.
Sponsored by Hospital General Universitario Gregorio Marañon · Phase 4, Interventional, and Treatment
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.
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.
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's enrollment of 302 is above the median of 64 across 379 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →Hospital General Universitario Gregorio Marañon is the lead sponsor of 59 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IV procainamide (single dose: 10 mg/kg over 20 min)
Drug: iv Procainamide
IV Amiodarone (single dose: 5 mg/kg over 20 min)
Drug: iv Amiodarone
To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation
Time frame: 40 minutes
To compare efficacy of both therapies in relation to episode termination
Time frame: 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
This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Hospital General Universitario Gregorio Marañon