Clinical Trial: Efficacy Study of Sodium Channel Blocker in LQT3 Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Ranolazine in LQT3 Patients
Brief Summary: The purpose of this study is to determine whether late sodium channel blockade might be effective in shortening the QTc interval in various LQT3 mutations and be considered as a safe therapeutic option for LQT3 patients.
Detailed Summary:
LQT3 mutations in the LQTS Registry will be studied using in vitro expression studies to determine whether ranolazine causes a decrease in late sodium current, slower recovery from inactivation and/or changes in time course of inactivation, ameliorating the causative functional effect of each individual mutation.
Individuals with select LQT3 mutations already studied in vitro will be invited to participate in a short term (2 day) study in the Clinical Research Center studying the effects of an oral dose of ranolazine on QTc duration and other ECG, echocardiogram and Holter-derived parameters.
The same individuals, as well as other individuals with the same mutation, will be invited to participate in a 6-month study involving ranolazine and matched placebo, to help evaluate the long-term effectiveness of ranolazine in the population. Periodic ECGs and 24-hour Holter recordings will be obtained for evaluation of QTc duration and other ECG and Holter-derived parameters.
Sponsor: University of Rochester
Current Primary Outcome: QTc duration [ Time Frame: At 2 and 6 months after baseline ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change in Novel ECG, Echo, and Holter-derived markers from baseline at 2 and 6 months [ Time Frame: At 2 months and 6 months ]
Original Secondary Outcome: Novel ECG, Echo, and Holter-derived markers [ Time Frame: At 2 months and 6 months ]
Information By: University of Rochester
Dates:
Date Received: July 18, 2012
Date Started: September 2012
Date Completion: December 2017
Last Updated: September 28, 2016
Last Verified: September 2016