Beta-2 Polymorphisms and Beta Receptor Selectivity
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Heart Failure |
| Intervention | Drug: Terbutaline plus Metoprolol or carvedilol |
| Phase | N/A |
| Sponsor | University of Wisconsin, Madison |
| Responsible Party | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier | NCT00214318 |
| First Received | September 14, 2005 |
| Last Updated | April 18, 2007 |
| Last verified | April 2007 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 14, 2005 |
|---|---|
| Last Updated Date | April 18, 2007 |
| Start Date | January 2005 |
| Estimated Primary Completion Date | February 2007 |
| Current Primary Outcome Measures | The effect of beta-2 polymorphisms on potassium changes in response to terbutaline infusions |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Beta-2 Polymorphisms and Beta Receptor Selectivity |
|---|---|
| Official Title | The Effects of ß2 Polymorphisms on Beta Selectivity After ß-Adrenergic Blockade in Patients With Heart Failure |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Heart Failure |
| Intervention | Drug: Terbutaline plus Metoprolol or carvedilol |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 25 |
| Estimated Completion Date | February 2007 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - systolic dysfunction with ejection fraction ≤40% - symptomatic heart failure class 2-3 - >18 years of age - optimal medical therapy of HF excluding the use of any beta-blockers within the previous 30 days of the study Exclusion Criteria: - active myocarditis - hemodynamically significant valvular heart disease - hypertrophic cardiomyopathy - contra-indications to beta-blockers - concomitant use of beta-agonists - beta-antagonist or anti-arrhythmics - unstable angina - myocardial infarction or bypass surgery within 3 months - significant renal insufficiency [creatinine >2.5 mg/dL], liver disease, or anemia |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00214318 |
|---|---|
| Other Study ID Numbers | M-2005-0006 |
| Has Data Monitoring Committee | No |
| Information Provided By | University of Wisconsin, Madison |
| Study Sponsor | University of Wisconsin, Madison |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: orly vardeny University of Wisconsin, Madison |
| Verification Date | April 2007 |
Locations[ + expand ][ + ]
| University of Wisconsin | Madison, Wisconsin, United States, 53792 |
|---|