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Beta-2 Polymorphisms and Beta Receptor Selectivity

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214318
First received: September 14, 2005
Last updated: April 18, 2007
Last verified: April 2007

September 14, 2005
April 18, 2007
January 2005
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The effect of beta-2 polymorphisms on potassium changes in response to terbutaline infusions
Same as current
Complete list of historical versions of study NCT00214318 on ClinicalTrials.gov Archive Site
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Beta-2 Polymorphisms and Beta Receptor Selectivity
The Effects of ß2 Polymorphisms on Beta Selectivity After ß-Adrenergic Blockade in Patients With Heart Failure

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Heart Failure
Drug: Terbutaline plus Metoprolol or carvedilol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2007
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214318
M-2005-0006
No
Not Provided
University of Wisconsin, Madison
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Principal Investigator: orly vardeny University of Wisconsin, Madison
University of Wisconsin, Madison
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP