Cytochrome P450 2D6 (CYP 450 2D6) Genotype and Flecainide... | NCT00945867

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

NCT00945867

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Apr 5, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Aug 2010Estimated

First Submitted Date

Jul 22, 2009

First Submission Date that Met QC Criteria

Jul 23, 2009

First Posted Date

Jul 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2011

Last Update Posted Date

Apr 5, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
no recurrence of atrial fibrillation		3 months

Secondary Outcomes

Measure	Description	Time Frame
the dose of flecainide used		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with atrial fibrillation and a normal heart.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Therese Fuchs, MD	Contact	972-8-977-8179		fuchst@asaf.health.gov.il

Overall Officials

Name	Affiliation	Role
Moshe Sharist, MD	Assaf-Harofeh Medical Center	Study Chair
Shmuel Bar-Haim, MD	Assaf-Harofeh Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf Harofeh Medical Center		Zrifin		00000	Israel

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided