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Genetic Determinants of Response to Beta Blockade

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
C. Michael Stein, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00837902
First received: February 4, 2009
Last updated: October 29, 2014
Last verified: October 2014

February 4, 2009
October 29, 2014
January 2009
December 2014   (final data collection date for primary outcome measure)
Attenuation of blood pressure and heart rate responses by atenolol [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00837902 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Genetic Determinants of Response to Beta Blockade
Genetic Determinants of Response to Beta Blockade

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

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.

Interventional
Not Provided
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy
Drug: Atenolol (β-blocker)
25 mg tablet
Other Name: generic atenolol is being used, so not applicable
Experimental: Atenolol
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
Intervention: Drug: Atenolol (β-blocker)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00837902
081267, P01 HL56693, U01 HL65962, UL 1 RR024975
No
C. Michael Stein, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Charles M Stein, MD Vanderbilt University
Vanderbilt University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP