Efficacy Study of Sodium Channel Blocker in LQT3 Patients

• Status: Completed
• Trial end date: 2018-07-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether late sodium channel blockade might be effective in shortening the QTc interval in various LQT3 mutations and be considered as a safe therapeutic option for LQT3 patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Gilead Sciences
• Treatments: Ranolazine; Sodium Channel Blockers

Criteria

Inclusion Criteria:

• Genotyped positive for LQT3 (SCN5A) mutation

• Age 21 years or older

• Not currently taking an antiarrhythmic drug (beta blockers are allowed)

• Enrolled in LQTS Registry

Exclusion Criteria:

• Age less than 21 years

• Not confirmed to have an LQT3 mutation

• Significant co-morbidity that would preclude subject's safe participation in this study

• Females who are pregnant or nursing

• Females of childbearing age who are not using acceptable method of birth control

• Evidence of prior sensitivity to ranolazine

• Hepatic or renal disease that might adversely affect ranolazine excretion

• Currently taking strong CYP3A inhibitors

• Currently taking P-gp inhibitors

• Currently taking CYP3A inducers

• In vitro studies of specific mutation show no effect of ranolazine on late sodium current kinetics or show repolarization prolongation