Beta-2 Polymorphisms and Beta Receptor Selectivity
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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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| 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 Heart Diseases Cardiovascular Diseases Metoprolol Carvedilol Terbutaline Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Sympathomimetics Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
ClinicalTrials.gov processed this record on May 16, 2013