Genetic Determinants of Response to Beta Blockade
4 other identifiers
interventional
154
1 country
1
Brief Summary
The overall goal of this project is to determine the genetic factors contributing to interindividual differences in response to beta-blockade.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jan 2009
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2014
CompletedResults Posted
Study results publicly available
November 30, 2018
CompletedNovember 30, 2018
November 1, 2018
4 years
February 4, 2009
September 21, 2018
November 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in Heart Rate
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.
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)
Study Arms (1)
Atenolol
EXPERIMENTALThere 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.
Interventions
25 mg tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University
Nashville, Tennessee, 37203, United States
Related Publications (1)
Kurnik D, Cunningham AJ, Sofowora GG, Kohli U, Li C, Friedman EA, Muszkat M, Menon UB, Wood AJ, Stein CM. GRK5 Gln41Leu polymorphism is not associated with sensitivity to beta(1)-adrenergic blockade in humans. Pharmacogenomics. 2009 Oct;10(10):1581-7. doi: 10.2217/pgs.09.92.
PMID: 19842931RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. C. Michael Stein
- Organization
- Vanderbilt University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Charles M Stein, MD
Vanderbilt University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dan May Professor of Medicine,. Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 6, 2009
Study Start
January 1, 2009
Primary Completion
December 31, 2012
Study Completion
December 31, 2014
Last Updated
November 30, 2018
Results First Posted
November 30, 2018
Record last verified: 2018-11