We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01728025
Recruitment Status : Unknown
Verified March 2015 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : November 16, 2012
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Long QT Syndrome Type 3 Drug: Ranolazine Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2012
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Ranolazine
Ranolazine 500-1000 mg twice a day as tolerated
 Drug: Ranolazine
Other Name: Ranexa


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants with syncope and/or documented ventricular arrhythmia [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Change in corrected QT interval [ Time Frame: within 30 days of initiation of Ranolazine treatment ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01728025


Contacts
Layout table for location contacts
Contact: Sami Viskin, MD 972-3-6973311 samiviskin@gmail.com
Contact: Jesaia Benhorin, MD 972-3-6973311

Locations
Layout table for location information
Israel
Tel Aviv Medical Center Recruiting
Tel Aviv, Israel
Contact: Sami Viskin, MD    972-3-6973311    samiviskin@gmail.com   
Principal Investigator: Sami Viskin, MD         
Sub-Investigator: Jesaia Benhorin, MD         
Sub-Investigator: Arnon Adler, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01728025    
Other Study ID Numbers: TASMC-12-SV-0363-10-CTIL
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015
Keywords provided by Tel-Aviv Sourasky Medical Center:
Long QT syndrome
Ranolazine
Additional relevant MeSH terms:
Layout table for MeSH terms
Long QT Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
 Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action