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Cytochrome P450 2D6 (CYP 450 2D6) Genotype and Flecainide Efficacy
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Assaf-Harofeh Medical Center.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
Assaf-Harofeh Medical Center
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00945867
First received: July 22, 2009
Last updated: April 4, 2011
Last verified: July 2009
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Purpose
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 |
|---|
| Atrial Fibrillation |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Assaf-Harofeh Medical Center:
Primary Outcome Measures:
- no recurrence of atrial fibrillation [ Time Frame: 3 months ]
Secondary Outcome Measures:
- the dose of flecainide used [ Time Frame: 6 months ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00945867
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | July 22, 2009 |
| Last Updated: | April 4, 2011 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017