Long Term Prophylactic Therapy of Congenital Long QT Syndrome Type III (LQT3) With Ranolazine
Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01728025
Collaborator
(none)
10
1
1
61
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Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Study Start Date
:
Oct 1, 2012
Anticipated Primary Completion Date
:
Nov 1, 2017
Anticipated Study Completion Date
:
Nov 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ranolazine Ranolazine 500-1000 mg twice a day as tolerated |
Drug: Ranolazine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of participants with syncope and/or documented ventricular arrhythmia [5 years]
Secondary Outcome Measures
- Change in corrected QT interval [within 30 days of initiation of Ranolazine treatment]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tel Aviv Medical Center | Tel Aviv | Israel |
Sponsors and Collaborators
- Tel-Aviv Sourasky Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
Responsible Party:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01728025
Other Study ID Numbers:
- TASMC-12-SV-0363-10-CTIL
First Posted:
Nov 16, 2012
Last Update Posted:
Mar 26, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Tel-Aviv Sourasky Medical Center
Additional relevant MeSH terms: