Efficacy Study of Sodium Channel Blocker in LQT3 Patients
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|ClinicalTrials.gov Identifier: NCT01648205|
Recruitment Status : Recruiting
First Posted : July 24, 2012
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Long QT Syndrome||Drug: Placebo Drug: Ranolazine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Ranolazine in LQT3 Patients|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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
- QTc duration [ Time Frame: At 2 and 6 months after baseline ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|