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Clinical Trials/NCT01728025
NCT01728025
Unknown
Phase 2

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

Tel-Aviv Sourasky Medical Center1 site in 1 country10 target enrollmentOctober 2012
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ConditionsLong QT Syndrome Type 3
InterventionsRanolazine
DrugsRanolazine

Overview

Phase
Phase 2
Intervention
Ranolazine
Conditions
Long QT Syndrome Type 3
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
10
Locations
1
Primary Endpoint
Number of participants with syncope and/or documented ventricular arrhythmia
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
November 2017
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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)

Arms & Interventions

Ranolazine

Ranolazine 500-1000 mg twice a day as tolerated

Intervention: Ranolazine

Outcomes

Primary Outcomes

Number of participants with syncope and/or documented ventricular arrhythmia

Time Frame: 5 years

Secondary Outcomes

  • Change in corrected QT interval(within 30 days of initiation of Ranolazine treatment)

Study Sites (1)

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