Beta-2 Polymorphisms and Beta Receptor Selectivity
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Terbutaline plus Metoprolol or carvedilol
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
- University of Wisconsin
Outcomes
Primary Outcome Measures
The effect of beta-2 polymorphisms on potassium changes in response to terbutaline infusions
Secondary Outcome Measures
Full Information
NCT ID
NCT00214318
First Posted
September 14, 2005
Last Updated
October 6, 2015
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00214318
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Terbutaline plus Metoprolol or carvedilol
Primary Outcome Measure Information:
Title
The effect of beta-2 polymorphisms on potassium changes in response to terbutaline infusions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
orly vardeny
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
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Beta-2 Polymorphisms and Beta Receptor Selectivity
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