Long Term Prophylactic Therapy of Congenital Long QT Syndrome Type III (LQT3) With Ranolazine

Long QT Syndrome Type 3 Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01728025
• Other study ID #: TASMC-12-SV-0363-10-CTIL
• Status: Recruiting
• Phase: Phase 2
• First received: November 12, 2012
• Last updated: March 25, 2015
• Start date: October 2012
• Est. completion date: November 2017

Study information

• Verified date: March 2015
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Sami Viskin, MD
• Phone: 972-3-6973311
• Email: samiviskin[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Long QT Syndrome
• Long QT Syndrome Type 3

Intervention

Drug:
• Ranolazine

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with syncope and/or documented ventricular arrhythmia		5 years	Yes
Secondary	Change in corrected QT interval		within 30 days of initiation of Ranolazine treatment	Yes