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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00945867
Recruitment Status : Unknown
Verified July 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 24, 2009
Last Update Posted : April 5, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Atrial Fibrillation

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.

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Use of CYP 450 2D6 Genotype as a Predictor of Flecainide Efficacy in the Treatment of Patients With Atrial Fibrillation
Study Start Date : September 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. no recurrence of atrial fibrillation [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. the dose of flecainide used [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with atrial fibrillation and a normal heart.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945867


Contacts
Contact: Therese Fuchs, MD 972-8-977-8179 fuchst@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Medical Center Not yet recruiting
Zrifin, Israel, 00000
Contact: Therese Fuchs, MD    972-8-977-8179    fuchst@asaf.health.gov.il   
Sub-Investigator: Moshe Sharist, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Chair: Moshe Sharist, MD Assaf-Harofeh Medical Center
Study Chair: Shmuel Bar-Haim, MD Assaf-Harofeh Medical Center
More Information

Responsible Party: Therese Fuchs, MD, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00945867     History of Changes
Other Study ID Numbers: 111/09
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: July 2009

Keywords provided by Assaf-Harofeh Medical Center:
flecainide
pharmacogenetics

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Flecainide
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action