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Trial record 29 of 116 for:    Atenolol

Genetic Determinants of Response to Beta Blockade

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ClinicalTrials.gov Identifier: NCT00837902
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
C. Michael Stein, Vanderbilt University

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Atenolol (β-blocker) 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Genetic Determinants of Response to Beta Blockade
Actual Study Start Date : January 2009
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : December 31, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Atenolol

Arm Intervention/treatment
Experimental: Atenolol

There is only 1 arm to this study. Intervention: All participants received atenolol. Genotyping for GRK5 was performed to identify if participants were GLN/GLN, GLN/LEU, or LEU/LEU.

Heart rates were measured at rest, and as participants performed graded incremental exercise on a supine bicycle ergometer (at 25, 50, and 75 W for 2 minutes each) twice, once before and once 2.5 hours after taking 25 mg of atenolol.

Drug: Atenolol (β-blocker)
25 mg tablet
Other Name: generic atenolol is being used, so not applicable




Primary Outcome Measures :
  1. Reduction in Heart Rate [ Time Frame: 2 exercise periods of 6 minutes each. 6 minutes of exercise before taking atenolol, and 6 minutes of exercise starting 2.5 hours after taking 25 mg of atenolol (2.5 hours + 6 minutes) ]
    Reduction in heart rate based upon genotype while exercising. Participants exercised on a recumbent bike for 2 minutes at 25W, 2 minutes at 50W, and 2 minutes at 75W twice, once before taking atenolol, and once 2.5 hours after oral administration of 25 mg of atenolol. Data points represent unadjusted mean reduction in heart rate in the 3 genotype groups.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837902


Locations
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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Investigators
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Principal Investigator: Charles M Stein, MD Vanderbilt University

Publications of Results:
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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
P01HL056693 ( U.S. NIH Grant/Contract )
U01HL065962 ( U.S. NIH Grant/Contract )
1UL1RR024975 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2009    Key Record Dates
Results First Posted: November 30, 2018
Last Update Posted: November 30, 2018
Last Verified: November 2018
Keywords provided by C. Michael Stein, Vanderbilt University:
Atenolol
Exercise
Genotype
Healthy volunteers
Additional relevant MeSH terms:
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Atenolol
Anti-Arrhythmia Agents
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