- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00945867
Cytochrome P450 2D6 (CYP 450 2D6) Genotype and Flecainide Efficacy
April 4, 2011 updated by: Assaf-Harofeh Medical Center
The Use of CYP 450 2D6 Genotype as a Predictor of Flecainide Efficacy in the Treatment of Patients With Atrial Fibrillation
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Therese Fuchs, MD
- Phone Number: 972-8-977-8179
- Email: fuchst@asaf.health.gov.il
Study Locations
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Zrifin, Israel, 00000
- Assaf Harofeh Medical Center
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Contact:
- Therese Fuchs, MD
- Phone Number: 972-8-977-8179
- Email: fuchst@asaf.health.gov.il
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Sub-Investigator:
- Moshe Sharist, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with atrial fibrillation and a normal heart.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
no recurrence of atrial fibrillation
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the dose of flecainide used
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Moshe Sharist, MD, Assaf-Harofeh Medical Center
- Study Chair: Shmuel Bar-Haim, MD, Assaf-Harofeh Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Anticipated)
March 1, 2010
Study Completion (Anticipated)
August 1, 2010
Study Registration Dates
First Submitted
July 22, 2009
First Submitted That Met QC Criteria
July 23, 2009
First Posted (Estimate)
July 24, 2009
Study Record Updates
Last Update Posted (Estimate)
April 5, 2011
Last Update Submitted That Met QC Criteria
April 4, 2011
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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