Beta-2 Polymorphisms and Beta Receptor Selectivity

NCT00214318 | Completed

• 1 other identifier: M-2005-0006
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

Interventions

Terbutaline plus Metoprolol or carvedilol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Terbutaline; Metoprolol; Carvedilol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenoxypropanolamines; Propanolamines; Propanols; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• orly vardeny

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2005
• Study Completion: February 1, 2007
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

US (1)