Efficacy Study of Sodium Channel Blocker in LQT3 Patients
This study is currently recruiting participants.
Verified June 2013 by University of Rochester
Sponsor:
University of Rochester
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Wojciech Zareba, University of Rochester
ClinicalTrials.gov Identifier:
NCT01648205
First received: July 18, 2012
Last updated: June 13, 2013
Last verified: June 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 18, 2012 | ||||||||
| Last Updated Date | June 13, 2013 | ||||||||
| Start Date ICMJE | September 2012 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01648205 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE |
Novel ECG, Echo, and Holter-derived markers [ 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. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy Study of Sodium Channel Blocker in LQT3 Patients | ||||||||
| Official Title ICMJE | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Long QT Syndrome | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Moss AJ, Zareba W, Schwarz KQ, Rosero S, McNitt S, Robinson JL. Ranolazine shortens repolarization in patients with sustained inward sodium current due to type-3 long-QT syndrome. J Cardiovasc Electrophysiol. 2008 Dec;19(12):1289-93. Epub 2008 Jul 25. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | September 2014 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01648205 | ||||||||
| Other Study ID Numbers ICMJE | IN-US-259-0128 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Wojciech Zareba, University of Rochester | ||||||||
| Study Sponsor ICMJE | University of Rochester | ||||||||
| Collaborators ICMJE | Gilead Sciences | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||||||
| Verification Date | June 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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