Overview

This trial is active, not recruiting.

Condition healthy
Treatment atenolol (β-blocker)
Sponsor Vanderbilt University
Start date January 2009
End date December 2016
Trial size 500 participants
Trial identifier NCT00837902, 081267, P01 HL56693, U01 HL65962, UL 1 RR024975

Summary

The overall goal of this project is to determine the genetic factors contributing to interindividual differences in response to beta-blockade.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
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
atenolol (β-blocker) generic atenolol is being used, so not applicable
25 mg tablet

Primary Outcomes

Measure
Attenuation of blood pressure and heart rate responses by atenolol
time frame: 4 hours

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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.

Additional Information

Official title Genetic Determinants of Response to Beta Blockade
Principal investigator Charles M Stein, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.