Cytochrome P450 2D6 (CYP 450 2D6) Genotype and Flecainide Efficacy

The Use of CYP 450 2D6 Genotype as a Predictor of Flecainide Efficacy in the Treatment of Patients With Atrial Fibrillation

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00945867

Enrollment

100

Registered

2009-07-24

Start date

2009-09-30

Completion date

2010-08-31

Last updated

2011-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

flecainide, pharmacogenetics

Brief summary

The determination of the 2D6 genotype will enable us to determine the way flecainide is metabolized by the liver. Some individuals are poor metabolizers and some individuals are extensive metabolizers of the drug. This will also determine which patients will benefit from the drug.

Detailed description

Pharmacogenetics is the study of genetic variations on drug metabolizing enzymes and transporters. Pharmacogenetics is one of the first clinical applications of the Human Genome Project. Pharmacogenomics is the study of the role of interindividual genomics variability on drug response, efficacy, and metabolism. It correlates the effects of the entire expressed genome to the clinical usefulness and toxicity of a drug. Pharmacogenomics has the potential to change the way patients' therapy is optimized, allowing an era of personalized medicine in which patients will be divided into groups based on genetic markers that treatment outcomes.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Patients with recurrent AF * Patients with a structurally normal heart * Patients \> 18 YO * Patients who signed an informed consent

Exclusion criteria

* Renal failure with creatinine clearance less than 40 * Elevated liver enzymes 3 times the normal range, or causing coagulation test abnormality * Pregnant patients * Patients treated with psychiatric agents

Design outcomes

Primary

Measure	Time frame
no recurrence of atrial fibrillation	3 months

Secondary

Measure	Time frame
the dose of flecainide used	6 months

Countries

Israel

Contacts

Primary ContactTherese Fuchs, MD

fuchst@asaf.health.gov.il972-8-977-8179

Outcome results