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

Shamir Medical Center (Assaf-Harofeh)

Status: Unknown

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Other

Identifiers

NCT00945867

111/09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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