Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT00214318
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Beta-2 Polymorphisms and Beta Receptor Selectivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013726', 'term': 'Terbutaline'}, {'id': 'D008790', 'term': 'Metoprolol'}, {'id': 'D000077261', 'term': 'Carvedilol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of beta-2 polymorphisms on potassium changes in response to terbutaline infusions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'We hypothesize that b2 adrenergic polymorphisms affect b-receptor selectivity in patients with heart failure treated with either a b1-selective or a b-nonselective agent. b-2 polymorphisms may contribute to differing responses to drug treatment with beta-blockers in heart failure. Characterizing these polymorphisms may help explain the variability in the degree of "selectivity" of action of b-blockers at the b receptor, namely if their action is specific for the b-1 or b-2 receptor. Part A was conducted at the University of Utah, and all subjects completed study related activities. Part B (sub-study) consists of genotyping of blood samples collected in part A, which will be completed at the University of Wisconsin. Sub-study (samples and DNA isolation) or Part B entailed analyzing an extra 10 mL of blood that was taken for DNA isolation. Genotyping (i.e. determination of genetic makeup) of beta adrenergic polymorphisms utilized polymerase chain reaction followed by pyrosequencing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systolic dysfunction with ejection fraction ≤40%\n* symptomatic heart failure class 2-3\n* \\>18 years of age\n* optimal medical therapy of HF excluding the use of any beta-blockers within the previous 30 days of the study\n\nExclusion Criteria:\n\n* active myocarditis\n* hemodynamically significant valvular heart disease\n* hypertrophic cardiomyopathy\n* contra-indications to beta-blockers\n* concomitant use of beta-agonists\n* beta-antagonist or anti-arrhythmics\n* unstable angina\n* myocardial infarction or bypass surgery within 3 months\n* significant renal insufficiency \\[creatinine \\>2.5 mg/dL\\], liver disease, or anemia'}, 'identificationModule': {'nctId': 'NCT00214318', 'briefTitle': 'Beta-2 Polymorphisms and Beta Receptor Selectivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'The Effects of ß2 Polymorphisms on Beta Selectivity After ß-adrenergic Blockade in Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'M-2005-0006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Terbutaline plus Metoprolol or carvedilol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'orly vardeny', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}