Trial record 4 of 23 for:    "Long QT syndrome"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01728025
First received: November 12, 2012
Last updated: May 20, 2014
Last verified: May 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01728025     History of Changes
Other Study ID Numbers: TASMC-12-SV-0363-10-CTIL
Study First Received: November 12, 2012
Last Updated: May 20, 2014
Health Authority: Israel: Ministry of Health

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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014