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 ]

Change from baseline in QTc at 2 months and at 6 months


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 ]

The investigators will evaluate the effects of ranolazine on novel ECG, echo and Holter-derived markers to determine whether they could be even more sensitive regarding effects of drug on repolarization and its dynamics, measuring changes from baseline at 2 months and at 6 months.


Original Secondary Outcome: Novel ECG, Echo, and Holter-derived markers [ Time Frame: At 2 months and 6 months ]

The investigators will evaluate the effects of ranolazine on novel ECG, echo and Holter-derived markers to determine whether they could be even more sensitive regarding effects of drug on repolarization and its dynamics, measuring changes from baseline at 2 months and at 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