Beta-2 Polymorphisms and Beta Receptor Selectivity

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terbutaline plus Metoprolol or carvedilol

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

The Effects of ß2 Polymorphisms on Beta Selectivity After ß-adrenergic Blockade in Patients With Heart Failure

Important dates

Study start: 2005
Study completion: 2007
First posted: Sep 21, 2005
Registry last updated: Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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