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Efficacy Study of Sodium Channel Blocker in LQT3 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01648205
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Wojciech Zareba, University of Rochester

Brief 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.

Condition or disease Intervention/treatment Phase
Long QT Syndrome Drug: Placebo Drug: Ranolazine Phase 2

Detailed Description:

LQT3 mutations in the LQTS Registry will be studied using in vitro expression studies to determine whether ranolazine causes a decrease in late sodium current, slower recovery from inactivation and/or changes in time course of inactivation, ameliorating the causative functional effect of each individual mutation.

Individuals with select LQT3 mutations already studied in vitro will be invited to participate in a short term (2 day) study in the Clinical Research Center studying the effects of an oral dose of ranolazine on QTc duration and other ECG, echocardiogram and Holter-derived parameters.

The same individuals, as well as other individuals with the same mutation, will be invited to participate in a 6-month study involving ranolazine and matched placebo, to help evaluate the long-term effectiveness of ranolazine in the population. Periodic ECGs and 24-hour Holter recordings will be obtained for evaluation of QTc duration and other ECG and Holter-derived parameters.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ranolazine in LQT3 Patients
Study Start Date : September 2012
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018


Arm Intervention/treatment
Active Comparator: Ranolazine
Ranolazine 1000 mg bid
Drug: Ranolazine
Patients will receive ranolazine 1000mg bid or matching placebo
Other Name: Raznexa

Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching Placebo will be given




Primary Outcome Measures :
  1. QTc duration [ Time Frame: At 2 and 6 months after baseline ]
    Change from baseline in QTc at 2 months and at 6 months


Secondary Outcome Measures :
  1. Change in Novel ECG, Echo, and Holter-derived markers from baseline at 2 and 6 months [ Time Frame: At 2 months and 6 months ]
    The investigators will evaluate the effects of ranolazine on novel ECG, echo and Holter-derived markers to determine whether they could be even more sensitive regarding effects of drug on repolarization and its dynamics, measuring changes from baseline at 2 months and at 6 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648205


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Gilead Sciences
Investigators
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Principal Investigator: Wojciech Zareba, MD,PhD University of Rochester

Publications:
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Responsible Party: Wojciech Zareba, Professor of Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT01648205     History of Changes
Other Study ID Numbers: IN-US-259-0128
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Keywords provided by Wojciech Zareba, University of Rochester:
ranolazine
clinical trial
Additional relevant MeSH terms:
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Long QT Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action