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

This study is currently recruiting participants.
Verified March 2015 by Tel-Aviv Sourasky Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01728025
First Posted: November 16, 2012
Last Update Posted: March 26, 2015
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
  Purpose
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 Intervention Phase
Long QT Syndrome Type 3 Drug: Ranolazine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

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

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

Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranolazine
Ranolazine 500-1000 mg twice a day as tolerated
Drug: Ranolazine
Other Name: Ranexa

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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
Contact: Sami Viskin, MD 972-3-6973311 samiviskin@gmail.com
Contact: Jesaia Benhorin, MD 972-3-6973311

Locations
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01728025     History of Changes
Other Study ID Numbers: TASMC-12-SV-0363-10-CTIL
First Submitted: November 12, 2012
First Posted: November 16, 2012
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:
Long QT Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action