Efficacy Study of Sodium Channel Blocker in 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:||December 2017|
|Estimated Primary Completion Date:||April 2017 (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
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: Kristina J Cutter, MS||585-275-8819||Kris.Cutter@heart.rochester.edu|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Kristina J Cutter, MS 585-275-8819 Kris.Cutter@heart.rochester.edu|
|Sub-Investigator: Spencer Z Rosero, MD|
|Principal Investigator:||Wojciech Zareba, MD,PhD||University of Rochester|