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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
  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 Intervention
Heart Failure
Drug: Terbutaline plus Metoprolol or carvedilol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effects of ß2 Polymorphisms on Beta Selectivity After ß-Adrenergic Blockade in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • The effect of beta-2 polymorphisms on potassium changes in response to terbutaline infusions

Estimated Enrollment: 25
Study Start Date: January 2005
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214318

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: orly vardeny University of Wisconsin, Madison
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00214318     History of Changes
Other Study ID Numbers: M-2005-0006
Study First Received: September 14, 2005
Last Updated: April 18, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014