Genetic Determinants of Response to Beta Blockade
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Atenolol (β-blocker) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
Charles M Stein, MD, Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
Charles M Stein, MD, Phone: 615-936-3420, Email: mike.stein@Vanderbilt.Edu
Summary
The overall goal of this project is to determine the genetic factors contributing to
interindividual differences in response to beta-blockade.
Clinical Details
Official title: Genetic Determinants of Response to Beta Blockade
Study design: Other, Open Label, Single Group Assignment, Pharmacodynamics Study
Primary outcome: Attenuation of blood pressure and heart rate responses by atenolol
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
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Charles M Stein, MD, Phone: 615-936-3420, Email: mike.stein@Vanderbilt.Edu
Vanderbilt University, Nashville, Tennessee 37203, United States; Recruiting
Charles M Stein, MD, Phone: 615-936-3420, Email: mike.stein@Vanderbilt.Edu
Charles M Stein, MD, Principal Investigator
Utkarsh Kohli, MD, Sub-Investigator
Additional Information
Starting date: January 2009
Ending date: December 2011
Last updated: February 5, 2009
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