Beta-2 Polymorphisms and Beta Receptor Selectivity

NCT ID: NCT00214318

Last Updated: 2015-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-02-28

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Terbutaline plus Metoprolol or carvedilol

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

orly vardeny

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

M-2005-0006

Identifier Type: -

Identifier Source: org_study_id