Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-29 @ 6:54 AM
Study NCT ID:
NCT00945867
Status:
UNKNOWN
Last Update Posted:
2011-04-05
First Post:
2009-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytochrome P450 2D6 (CYP 450 2D6) Genotype and Flecainide Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-04', 'studyFirstSubmitDate': '2009-07-22', 'studyFirstSubmitQcDate': '2009-07-23', 'lastUpdatePostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'no recurrence of atrial fibrillation', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'the dose of flecainide used', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['flecainide', 'pharmacogenetics'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with atrial fibrillation and a normal heart.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with recurrent AF\n* Patients with a structurally normal heart\n* Patients \\> 18 YO\n* Patients who signed an informed consent\n\nExclusion Criteria:\n\n* Renal failure with creatinine clearance less than 40\n* Elevated liver enzymes 3 times the normal range, or causing coagulation test abnormality\n* Pregnant patients\n* Patients treated with psychiatric agents'}, 'identificationModule': {'nctId': 'NCT00945867', 'briefTitle': 'Cytochrome P450 2D6 (CYP 450 2D6) Genotype and Flecainide Efficacy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'The Use of CYP 450 2D6 Genotype as a Predictor of Flecainide Efficacy in the Treatment of Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': '111/09'}}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Zrifin', 'country': 'Israel', 'contacts': [{'name': 'Therese Fuchs, MD', 'role': 'CONTACT', 'email': 'fuchst@asaf.health.gov.il', 'phone': '972-8-977-8179'}, {'name': 'Moshe Sharist, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Assaf Harofeh Medical Center'}], 'centralContacts': [{'name': 'Therese Fuchs, MD', 'role': 'CONTACT', 'email': 'fuchst@asaf.health.gov.il', 'phone': '972-8-977-8179'}], 'overallOfficials': [{'name': 'Moshe Sharist, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assaf-Harofeh Medical Center'}, {'name': 'Shmuel Bar-Haim, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assaf-Harofeh Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Therese Fuchs, MD', 'oldOrganization': 'Assaf Harofeh Medical Center'}}}}