Long QT Syndrome Clinical Trial
Official title:
Efficacy of Ranolazine in LQT3 Patients
Verified date | March 2022 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether late sodium channel blockade might be effective in shortening the QTc interval in various LQT3 mutations and be considered as a safe therapeutic option for LQT3 patients.
Status | Completed |
Enrollment | 25 |
Est. completion date | July 20, 2018 |
Est. primary completion date | July 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Genotyped positive for LQT3 (SCN5A) mutation - Age 21 years or older - Not currently taking an antiarrhythmic drug (beta blockers are allowed) - Enrolled in LQTS Registry Exclusion Criteria: - Age less than 21 years - Not confirmed to have an LQT3 mutation - Significant co-morbidity that would preclude subject's safe participation in this study - Females who are pregnant or nursing - Females of childbearing age who are not using acceptable method of birth control - Evidence of prior sensitivity to ranolazine - Hepatic or renal disease that might adversely affect ranolazine excretion - Currently taking strong CYP3A inhibitors - Currently taking P-gp inhibitors - Currently taking CYP3A inducers - In vitro studies of specific mutation show no effect of ranolazine on late sodium current kinetics or show repolarization prolongation |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | Gilead Sciences |
United States,
Benhorin J, Taub R, Goldmit M, Kerem B, Kass RS, Windman I, Medina A. Effects of flecainide in patients with new SCN5A mutation: mutation-specific therapy for long-QT syndrome? Circulation. 2000 Apr 11;101(14):1698-706. — View Citation
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. — View Citation
Schwartz PJ, Priori SG, Locati EH, Napolitano C, Cantù F, Towbin JA, Keating MT, Hammoude H, Brown AM, Chen LS, Colatsky TJ. Long QT syndrome patients with mutations of the SCN5A and HERG genes have differential responses to Na+ channel blockade and to increases in heart rate. Implications for gene-specific therapy. Circulation. 1995 Dec 15;92(12):3381-6. — View Citation
Zareba W, Moss AJ, Locati EH, Lehmann MH, Peterson DR, Hall WJ, Schwartz PJ, Vincent GM, Priori SG, Benhorin J, Towbin JA, Robinson JL, Andrews ML, Napolitano C, Timothy K, Zhang L, Medina A; International Long QT Syndrome Registry. Modulating effects of age and gender on the clinical course of long QT syndrome by genotype. J Am Coll Cardiol. 2003 Jul 2;42(1):103-9. — View Citation
Zareba W, Moss AJ, Schwartz PJ, Vincent GM, Robinson JL, Priori SG, Benhorin J, Locati EH, Towbin JA, Keating MT, Lehmann MH, Hall WJ. Influence of the genotype on the clinical course of the long-QT syndrome. International Long-QT Syndrome Registry Research Group. N Engl J Med. 1998 Oct 1;339(14):960-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in QTc Duration at 2 Months | Change in QTc at 2 months on ranolazine vs. at 1 month on placebo. This was prespecified outcome. | 1 month to 2 months | |
Secondary | Change in QTc at 6 Months | Change in QTc at 6 months on ranolazine vs. at 1 month on placebo. This was prespecified outcome. | 1 month to 6 months |
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