Genetic Determinants of Response to Beta Blockade
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Purpose
The overall goal of this project is to determine the genetic factors contributing to interindividual differences in response to beta-blockade.
| Condition | Intervention |
|---|---|
|
Healthy |
Drug: Atenolol (β-blocker) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Genetic Determinants of Response to Beta Blockade |
- Attenuation of blood pressure and heart rate responses by atenolol [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Atenolol
pharmacodynamic measures are obtained in subjects before and after administration of atenolol
|
Drug: Atenolol (β-blocker)
25 mg tablet
|
Detailed Description:
The Aim is to define the contribution of genetic variation to the interindividual variability in response to β-blockade. The rationale for the study is as follows: Beta-blockers prevent the activation of β-ARs and thus form the cornerstone of treatment of pathological states such as congestive heart failure and coronary artery disease. Functional polymorphisms in cardiac beta-receptors have been shown to determine response to β-blocker therapy. A physiologic stimulus such as exercise causes sympathetic stimulation and activation of the cardiac β-ARs and genotypic differences in response to β-blockers are magnified under states of heightened sympathetic activity. Thus, in addition to measuring the response to β-blockers at rest, we will also determine the response to β-blockade after sub-maximal exercise on a supine bicycle ergometer. Genetic variations that may alter sensitivity to a beta blocker will be sought.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subject must be willing to give written informed consent and be able to adhere to diet and study schedules.
- Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations.
- Subjects must have a clinically acceptable physical examination and ECG.
- Laboratory tests (CBC, blood chemistries, and urinalysis) must be within clinically acceptable limits.
Exclusion Criteria:
- Any subject who has taken any prescription or over-the-counter drugs, other than oral contraception if female, within one week prior to study drug administration.
- Subjects who are presently, or were formerly, narcotic addicts or alcoholics.
- Active smokers.
- Subjects who have a clinically significant allergy/intolerance to atenolol.
- Females with a positive serum/urine pregnancy test at screening.
- Females who are nursing.
- Subjects with complete heart block/ any other significant cardiovascular disease.
- Subjects with a history of asthma symptoms or medication for it within last 10 years.
- Subjects who have a systolic blood pressure < 90 mm Hg or diastolic blood pressure < 50 mm Hg or heart rate < 50/min at the screening visit or on the baseline pre drug values on the study day.
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37203 | |
| Principal Investigator: | Charles M Stein, MD | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | C. Michael Stein, Dan May Professor of Medicine,. Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00837902 History of Changes |
| Other Study ID Numbers: | 081267, P01 HL56693, U01 HL65962, UL 1 RR024975 |
| Study First Received: | February 4, 2009 |
| Last Updated: | January 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
Atenolol Exercise Genotype Healthy volunteers |
Additional relevant MeSH terms:
|
Atenolol 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 |
ClinicalTrials.gov processed this record on May 19, 2013