Back to resultsLong Term Prophylactic Therapy of Congenital Long QT Syndrome Type III (LQT3) With Ranolazine
Primary Purpose
Long QT Syndrome Type 3
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Ranolazine
Sponsored by
About this trial
This is an interventional prevention trial for Long QT Syndrome Type 3 focused on measuring Long QT syndrome, Ranolazine
Eligibility Criteria
Inclusion Criteria:
- Long QT patients with genetic confirmation of carrier-status for the D1790G mutation in the SCN5A gene
- Corrected QT interval > 460 msec
Exclusion Criteria:
- Need for therapy with medications that are potent or moderately potent CYP3A inhibitors (such as ketoconazole, diltiazem, verapamil, macrolide antibiotics or HIV protease inhibitors)
Sites / Locations
- Tel Aviv Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ranolazine
Arm Description
Ranolazine 500-1000 mg twice a day as tolerated
Outcomes
Primary Outcome Measures
Number of participants with syncope and/or documented ventricular arrhythmia
Secondary Outcome Measures
Change in corrected QT interval
Full Information
NCT ID
NCT01728025
First Posted
November 12, 2012
Last Updated
March 25, 2015
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01728025
Brief Title
Long Term Prophylactic Therapy of Congenital Long QT Syndrome Type III (LQT3) With Ranolazine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether ranolazine will reduce the risk of arrhythmic events in patients with long QT syndrome type 3.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long QT Syndrome Type 3
Keywords
Long QT syndrome, Ranolazine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ranolazine
Arm Type
Experimental
Arm Description
Ranolazine 500-1000 mg twice a day as tolerated
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa
Primary Outcome Measure Information:
Title
Number of participants with syncope and/or documented ventricular arrhythmia
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Change in corrected QT interval
Time Frame
within 30 days of initiation of Ranolazine treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Long QT patients with genetic confirmation of carrier-status for the D1790G mutation in the SCN5A gene
Corrected QT interval > 460 msec
Exclusion Criteria:
Need for therapy with medications that are potent or moderately potent CYP3A inhibitors (such as ketoconazole, diltiazem, verapamil, macrolide antibiotics or HIV protease inhibitors)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sami Viskin, MD
Phone
972-3-6973311
Email
samiviskin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jesaia Benhorin, MD
Phone
972-3-6973311
Facility Information:
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sami Viskin, MD
Phone
972-3-6973311
Email
samiviskin@gmail.com
First Name & Middle Initial & Last Name & Degree
Sami Viskin, MD
First Name & Middle Initial & Last Name & Degree
Jesaia Benhorin, MD
First Name & Middle Initial & Last Name & Degree
Arnon Adler, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
18662191
Citation
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. doi: 10.1111/j.1540-8167.2008.01246.x. Epub 2008 Jul 25.
Results Reference
background
PubMed Identifier
19371746
Citation
Lindegger N, Hagen BM, Marks AR, Lederer WJ, Kass RS. Diastolic transient inward current in long QT syndrome type 3 is caused by Ca2+ overload and inhibited by ranolazine. J Mol Cell Cardiol. 2009 Aug;47(2):326-34. doi: 10.1016/j.yjmcc.2009.04.003. Epub 2009 Apr 14.
Results Reference
background
PubMed Identifier
27733495
Citation
Chorin E, Hu D, Antzelevitch C, Hochstadt A, Belardinelli L, Zeltser D, Barajas-Martinez H, Rozovski U, Rosso R, Adler A, Benhorin J, Viskin S. Ranolazine for Congenital Long-QT Syndrome Type III: Experimental and Long-Term Clinical Data. Circ Arrhythm Electrophysiol. 2016 Oct;9(10):e004370. doi: 10.1161/CIRCEP.116.004370.
Results Reference
derived
Learn more about this trial
Long Term Prophylactic Therapy of Congenital Long QT Syndrome Type III (LQT3) With Ranolazine
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