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

Phase 2

• Conditions: Long QT Syndrome Type 3
• Interventions: Drug: Ranolazine

• Registration Number: NCT01728025
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-16
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranolazine	Ranolazine	Ranolazine 500-1000 mg twice a day as tolerated

Primary Outcome Measures

Name	Time	Method
Number of participants with syncope and/or documented ventricular arrhythmia	5 years

Secondary Outcome Measures

Name	Time	Method
Change in corrected QT interval	within 30 days of initiation of Ranolazine treatment

Trial Locations

Locations (1)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel