Status:
COMPLETED
Effect of Ranolazine on Arrhythmias and Microvolt T- Wave Alternans (MVTWA) Patients With LV Dysfunction
Lead Sponsor:
Aspirus Heart and Vascular Institute-Research and Education
Conditions:
Sudden Cardiac Death
Ventricular Arrythmias
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose this investigation is to more thoroughly investigate the effects of ranolazine on arrhythmias and microvolt t-wave alternans in patients who have an automatic implantable cardioverter defi...
Detailed Description
The device clinic of Aspirus Wausau Hospital follows approximately 2800 patients with pacemakers and automatic implantable cardioverter defibrillators (AICD). Approximately 300 of these patients have ...
Eligibility Criteria
Inclusion
- Implant of AICD for the prevention of sudden cardiac death Implant of AICD for the prevention of sudden cardiac death
Exclusion
- Any anti-arrhythmic agent (other than beta-blockers)
- History of or intolerance to ranolazine during the run in.
- History of severe constipation defined as requiring laxatives more than 5 times a week in order to have a bowel movement.
- Because of a weak inhibitory effect of ranolazine of the cytochrome p450, CYP 3A4, certain drugs metabolized by that system could accumulate. Although clinically significant interactions of ranolazine with these agents has not been demonstrated, patients on maximum doses of simvastatin, or patients on verapamil or diltiazem will be excluded.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00998218
Start Date
September 1 2009
End Date
December 1 2010
Last Update
February 9 2012
Active Locations (1)
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1
Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401