Genetic Determinants of Response to Beta Blockade - Full Text View

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00837902

Purpose

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

Condition	Intervention
Healthy	Drug: Atenolol (β-blocker)

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Pharmacodynamics Study
Official Title:	Genetic Determinants of Response to Beta Blockade

Resource links provided by NLM:

Drug Information available for: Atenolol

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Attenuation of blood pressure and heart rate responses by atenolol [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Atenolol: Experimental pharmacodynamic measures are obtained in subjects before and after administration of atenolol	Drug: Atenolol (β-blocker) 25 mg tablet

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

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837902

Contacts

Contact: Charles M Stein, MD	615-936-3420	mike.stein@Vanderbilt.Edu
Contact: Utkarsh Kohli, MD	615-343-3512	utkarsh.kohli@Vanderbilt.Edu

Locations

United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37203
Contact: Charles M Stein, MD 615-936-3420 mike.stein@Vanderbilt.Edu
Principal Investigator: Charles M Stein, MD
Sub-Investigator: Utkarsh Kohli, MD

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Charles M Stein, MD

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University ( Dr. CM Stein )
Study ID Numbers:	081267, P01 HL56693, U01 HL65962, UL 1 RR024975
Study First Received:	February 4, 2009
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00837902 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Atenolol
Exercise
Genotype
Healthy volunteers

Additional relevant MeSH terms:

Sympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Atenolol

ClinicalTrials.gov processed this record on February 08, 2010