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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014