Long Term Prophylactic Therapy of Congenital Long QT Synd... | NCT01728025

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

NCT01728025

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Mar 26, 2015Estimated

Enrollment

10Estimated

Phase

Phase 2

Conditions

Long QT Syndrome Type 3

Interventions

Ranolazine

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Nov 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Nov 12, 2012

First Submission Date that Met QC Criteria

Nov 12, 2012

First Posted Date

Nov 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2015

Last Update Posted Date

Mar 26, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ranolazine	Experimental	Ranolazine 500-1000 mg twice a day as tolerated	Drug: Ranolazine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ranolazine	Drug		Ranolazine	Ranexa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with syncope and/or documented ventricular arrhythmia		5 years

Secondary Outcomes

Measure	Description	Time Frame
Change in corrected QT interval		within 30 days of initiation of Ranolazine treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sami Viskin, MD	Contact	972-3-6973311		samiviskin@gmail.com
Jesaia Benhorin, MD	Contact	972-3-6973311

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel Aviv Medical Center	Recruiting	Tel Aviv			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18662191	Background	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.
19371746	Background

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000075224	Cardiac Conduction System Disease

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814