Long Term Prophylactic Therapy of Congenital Long QT Syndrome Type III (LQT3) With Ranolazine
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2012
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 12, 2012
CompletedFirst Posted
Study publicly available on registry
November 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedMarch 26, 2015
March 1, 2015
5.1 years
November 12, 2012
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with syncope and/or documented ventricular arrhythmia
5 years
Secondary Outcomes (1)
Change in corrected QT interval
within 30 days of initiation of Ranolazine treatment
Study Arms (1)
Ranolazine
EXPERIMENTALRanolazine 500-1000 mg twice a day as tolerated
Interventions
Eligibility Criteria
You may qualify if:
- Long QT patients with genetic confirmation of carrier-status for the D1790G mutation in the SCN5A gene
- Corrected QT interval \> 460 msec
You may not qualify if:
- Need for therapy with medications that are potent or moderately potent CYP3A inhibitors (such as ketoconazole, diltiazem, verapamil, macrolide antibiotics or HIV protease inhibitors)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv Medical Center
Tel Aviv, Israel
Related Publications (3)
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.
PMID: 18662191BACKGROUNDLindegger 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.
PMID: 19371746BACKGROUNDChorin 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.
PMID: 27733495DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2012
First Posted
November 16, 2012
Study Start
October 1, 2012
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
March 26, 2015
Record last verified: 2015-03