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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00945867
• Other study ID #: 111/09
• Status: Not yet recruiting
• Phase: N/A
• First received: July 22, 2009
• Last updated: April 4, 2011
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: July 2009
• Source: Assaf-Harofeh Medical Center
• Contact: Therese Fuchs, MD
• Phone: 972-8-977-8179
• Email: fuchst[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	no recurrence of atrial fibrillation		3 months	No
Secondary	the dose of flecainide used		6 months	No