Efficacy Study of Sodium Channel Blocker in LQT3 Patients
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Ranolazine in LQT3 Patients|
- QTc duration [ Time Frame: At 2 and 6 months after baseline ] [ Designated as safety issue: No ]Change from baseline in QTc at 2 months and at 6 months
- Change in Novel ECG, Echo, and Holter-derived markers from baseline at 2 and 6 months [ Time Frame: At 2 months and 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Ranolazine
Ranolazine 1000 mg bid
Patients will receive ranolazine 1000mg bid or matching placebo
Other Name: Raznexa
Placebo Comparator: Placebo
Matching Placebo will be given
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648205
|Contact: Jennifer L Robinson, MS||585-275-8819||Jennifer.Robinson@heart.rochester.edu|
|Contact: Kristina J Cutter, MS||585-275-8825||Kris.Cutter@heart.rochester.edu|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Jennifer L Robinson, MS 585-275-8819 Jennifer.Robinson@heart.rochester.edu|
|Contact: Kristina J Cutter, MS 585-275-8825 Kris.Cutter@heart.rochester.edu|
|Sub-Investigator: Spencer Z Rosero, MD|
|Principal Investigator:||Wojciech Zareba, MD,PhD||University of Rochester|