Beta-2 Polymorphisms and Beta Receptor Selectivity
Information source: University of Wisconsin, Madison
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Terbutaline plus Metoprolol or carvedilol (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s):
orly vardeny, Principal Investigator, Affiliation: University of Wisconsin, Madison
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.
Clinical Details
Official title: The Effects of ß2 Polymorphisms on Beta Selectivity After ß-Adrenergic Blockade in Patients With Heart Failure
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The effect of beta-2 polymorphisms on potassium changes in response to terbutaline infusions
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Wisconsin, Madison, Wisconsin 53792, United States
Additional Information
Starting date: January 2005
Ending date: February 2007
Last updated: April 18, 2007
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