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: July 3, 2013
Last verified: July 2013
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 2014 (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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
||July 3, 2013
||United States: Institutional Review Board
Keywords provided by Vanderbilt University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action