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Trial record 29 of 117 for:    Atenolol

Genetic Determinants of Response to Beta Blockade

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Intervention Drug: Atenolol (β-blocker)
Enrollment 154
Recruitment Details  
Pre-assignment Details  
Arm/Group Title White Participants--Atenolol Black Participants-Atenolol
Hide Arm/Group Description Unrelated white American subjects Unrelated black American subjects
Period Title: Overall Study
Started 85 69
Completed 85 69
Not Completed 0 0
Arm/Group Title White Participants--Atenolol Black Participants-Atenolol Total
Hide Arm/Group Description Unrelated black and white American subjects were eligible to participate if they were between 18 and 50 years old and had no clinically significant abnormality based on medical history, physical exam, electrocardiogram and routine laboratory testing. Subjects were free of medications for at least 1 week. They also received an alcohol and caffeine free diet for 6 days prior to the study. Unrelated black and white American subjects were eligible to participate if they were between 18 and 50 years old and had no clinically significant abnormality based on medical history, physical exam, electrocardiogram and routine laboratory testing. Subjects were free of medications for at least 1 week. They also received an alcohol and caffeine free diet for 6 days prior to the study Total of all reporting groups
Overall Number of Baseline Participants 85 69 154
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants 69 participants 154 participants
27.0  (6.4) 25.9  (6) 26.5  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 69 participants 154 participants
Female
40
  47.1%
47
  68.1%
87
  56.5%
Male
45
  52.9%
22
  31.9%
67
  43.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 85 participants 69 participants 154 participants
85 69 154
systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 85 participants 69 participants 154 participants
109.9  (11.4) 112.5  (12.1) 111.1  (11.8)
diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 85 participants 69 participants 154 participants
64.0  (6.8) 66.2  (7.5) 65.0  (7.1)
GRK5 Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 69 participants 154 participants
GLN/GLN
85
 100.0%
29
  42.0%
114
  74.0%
GLN/LEU
0
   0.0%
35
  50.7%
35
  22.7%
LEU/LEU
0
   0.0%
5
   7.2%
5
   3.2%
1.Primary Outcome
Title Reduction in Heart Rate
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
There are 3 genotypes for GRK5, GLN/GLN, GLN/LEU, and LEU/LEU. A priori analysis plan was to compare reduction in heart rate among the 3 genotypes..
Arm/Group Title GLN/GLN GLN/LEU LEU/LEU
Hide Arm/Group Description:
One of 3 genotypes for GRK5, GLN/GLN
One of 3 genotypes for GRK5, GLN/LEU
One of 3 genotypes for GRK5, LEU/LEU.
Overall Number of Participants Analyzed 114 35 5
Mean (Standard Deviation)
Unit of Measure: beats per minute
0, baseline 7.9  (7) 6  (5.9) 3.3  (5.4)
2 minutes from baseline, 2 minutes exercise at 25W 9.6  (8.2) 8.4  (7.7) 7.4  (4.4)
4 minutes from baseline, 2 minutes exercise at 50W 11.7  (7) 10.9  (7.2) 9.1  (3.4)
6 minutes from baseline, 2 minutes exercise at 75W 14  (8) 12.4  (9.1) 10  (6.1)
Time Frame 7 days. Participants were placed on an alcohol and caffeine free diet for 6 days prior to the study, which provided 150 mmol of sodium, 70mmol of potassium, and 600 mmol of calcium daily, and the study day.
Adverse Event Reporting Description no adverse events
 
Arm/Group Title White Participants--Atenolol Black Participants-Atenolol
Hide Arm/Group Description Unrelated black and white American subjects were eligible to participate if they were between 18 and 50 years old and had no clinically significant abnormality based on medical history, physical exam, electrocardiogram and routine laboratory testing. Subjects were free of medications for at least 1 week. They also received an alcohol and caffeine free diet for 6 days prior to the study. Unrelated black and white American subjects were eligible to participate if they were between 18 and 50 years old and had no clinically significant abnormality based on medical history, physical exam, electrocardiogram and routine laboratory testing. Subjects were free of medications for at least 1 week. They also received an alcohol and caffeine free diet for 6 days prior to the study
All-Cause Mortality
White Participants--Atenolol Black Participants-Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/69 (0.00%) 
Hide Serious Adverse Events
White Participants--Atenolol Black Participants-Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/69 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
White Participants--Atenolol Black Participants-Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/85 (0.00%)   0/69 (0.00%) 
We cannot extrapolate our results to subjects substantially different from our study group, such as elderly subjects, cardiac patients, or patients on on chronic beta-blocker therapy, or disease states such as heart failure.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. C. Michael Stein
Organization: Vanderbilt University Medical Center
Phone: 615-936-3420
EMail: mike.stein@vumc.org
Layout table for additonal information
Responsible Party: C. Michael Stein, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00837902    
Other Study ID Numbers: 081267
P01HL056693 ( U.S. NIH Grant/Contract )
U01HL065962 ( U.S. NIH Grant/Contract )
1UL1RR024975 ( U.S. NIH Grant/Contract )
First Submitted: February 4, 2009
First Posted: February 6, 2009
Results First Submitted: September 21, 2018
Results First Posted: November 30, 2018
Last Update Posted: November 30, 2018