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: July 3, 2013
Last verified: July 2013
  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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Genetic Determinants of Response to Beta Blockade

Resource links provided by NLM:


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 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Atenolol (β-blocker)
25 mg tablet
Other Name: generic atenolol is being used, so not applicable

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

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Charles M Stein, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: C. Michael Stein, Dan May Professor of Medicine,. Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00837902     History of Changes
Other Study ID Numbers: 081267, P01 HL56693, U01 HL65962, UL 1 RR024975
Study First Received: February 4, 2009
Last Updated: July 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Atenolol
Exercise
Genotype
Healthy volunteers

Additional relevant MeSH terms:
Atenolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014