Genetic Determinants of Response to Beta Blockade
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
C. Michael Stein, Vanderbilt University
First received: February 4, 2009
Last updated: June 16, 2015
Last verified: June 2015
The overall goal of this project is to determine the genetic factors contributing to interindividual differences in response to beta-blockade.
Drug: Atenolol (β-blocker)
||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
||Genetic Determinants of Response to Beta Blockade
Primary Outcome Measures:
- Attenuation of blood pressure and heart rate responses by atenolol [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
There is only 1 arm to this study. Intervention: administration of atenolol. Pharmacodynamic measures will be obtained in subjects before administration of atenonol and after administration of atenolol
Drug: Atenolol (β-blocker)
25 mg tablet
Other Name: generic atenolol is being used, so not applicable
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.
|Ages Eligible for Study:
||18 Years to 40 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00837902
|Nashville, Tennessee, United States, 37203 |
||Charles M Stein, MD
No publications provided
||C. Michael Stein, Dan May Professor of Medicine,. Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology, Vanderbilt University
History of Changes
|Other Study ID Numbers:
||081267, P01 HL56693, U01 HL65962, UL 1 RR024975
|Study First Received:
||February 4, 2009
||June 16, 2015
||United States: Institutional Review Board
Keywords provided by Vanderbilt University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 09, 2015
Adrenergic beta-1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs