- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00214318
Beta-2 Polymorphisms and Beta Receptor Selectivity
October 6, 2015 updated by: University of Wisconsin, Madison
The Effects of ß2 Polymorphisms on Beta Selectivity After ß-adrenergic Blockade in Patients With Heart Failure
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The effect of beta-2 polymorphisms on potassium changes in response to terbutaline infusions
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: orly vardeny, University of Wisconsin, Madison
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
October 8, 2015
Last Update Submitted That Met QC Criteria
October 6, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Heart Failure
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic Agonists
- Membrane Transport Modulators
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Antioxidants
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Sympathomimetics
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Metoprolol
- Carvedilol
- Terbutaline
Other Study ID Numbers
- M-2005-0006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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