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

NCT ID: NCT01728025

Last Updated: 2015-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Long QT Syndrome Type 3

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ranolazine

Ranolazine 500-1000 mg twice a day as tolerated

Group Type EXPERIMENTAL

Ranolazine

Intervention Type DRUG

Interventions

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Ranolazine

Intervention Type DRUG

Other Intervention Names

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Ranexa

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Sami Viskin, MD

Role: CONTACT

972-3-6973311

Jesaia Benhorin, MD

Role: CONTACT

972-3-6973311

Facility Contacts

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Sami Viskin, MD

Role: primary

972-3-6973311

References

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Moss AJ, Zareba W, Schwarz KQ, Rosero S, McNitt S, Robinson JL. Ranolazine shortens repolarization in patients with sustained inward sodium current due to type-3 long-QT syndrome. J Cardiovasc Electrophysiol. 2008 Dec;19(12):1289-93. doi: 10.1111/j.1540-8167.2008.01246.x. Epub 2008 Jul 25.

Reference Type BACKGROUND
PMID: 18662191 (View on PubMed)

Lindegger N, Hagen BM, Marks AR, Lederer WJ, Kass RS. Diastolic transient inward current in long QT syndrome type 3 is caused by Ca2+ overload and inhibited by ranolazine. J Mol Cell Cardiol. 2009 Aug;47(2):326-34. doi: 10.1016/j.yjmcc.2009.04.003. Epub 2009 Apr 14.

Reference Type BACKGROUND
PMID: 19371746 (View on PubMed)

Chorin E, Hu D, Antzelevitch C, Hochstadt A, Belardinelli L, Zeltser D, Barajas-Martinez H, Rozovski U, Rosso R, Adler A, Benhorin J, Viskin S. Ranolazine for Congenital Long-QT Syndrome Type III: Experimental and Long-Term Clinical Data. Circ Arrhythm Electrophysiol. 2016 Oct;9(10):e004370. doi: 10.1161/CIRCEP.116.004370.

Reference Type DERIVED
PMID: 27733495 (View on PubMed)

Other Identifiers

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TASMC-12-SV-0363-10-CTIL

Identifier Type: -

Identifier Source: org_study_id

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