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Genetically Determined Response to Atenolol in Patients With Persistent Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT01719367
Recruitment Status : Completed
First Posted : November 1, 2012
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Vanderbilt University Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atrial Fibrillation
Intervention Drug: Atenolol
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atenolol: Ancestral Alleles Atenolol: Variant Carriers
Hide Arm/Group Description

Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.

participants have Ancestral Alleles

Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.

participants have Variant Carriers

Period Title: Overall Study
Started 19 19
Completed 19 19
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description all participants
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
The PI of this study left Vanderbilt. Limited data are available for this study. Baseline data are not available per-arm, therefore, only the baseline data for overall population is being reported.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 38 participants
70.5
(60 to 74.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
4
  10.5%
Male
34
  89.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
38
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants
19
1.Primary Outcome
Title Change in Pre- and Post-atenolol Ventricular Rate Response After 5 Minutes of Exercise
Hide Description After baseline vital signs and ECG are recorded, patients will be asked to perform a baseline standardized (modified Bruce) exercise protocol. Heart rate will be recorded during each stage of the exercise protocol. Patients will be asked to exercise to sub-maximal exertion. After the baseline exercise protocol, patients will be given a single dose of oral atenolol. After a two hour waiting period to allow for peak effect of atenolol, patients will repeat the exercise protocol. The primary study outcome measure will be the difference in pre- and post-atenolol ventricular rate response to exercise. The primary outcome measure will be compared in patients with various polymorphisms in genes that might play a role in the inter-individual response to atenolol.
Time Frame after 5minutes of exercise
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol: Ancestral Alleles Atenolol: Variant Carriers
Hide Arm/Group Description:

Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.

These patients have Ancestral Alleles

Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.

These patients have Variant Carriers

Overall Number of Participants Analyzed 19 19
Mean (95% Confidence Interval)
Unit of Measure: beats per minute
-10
(-18.6 to -1.4)
-13
(-20.2 to -5.8)
2.Primary Outcome
Title Change in Pre- and Post-atenolol Ventricular Rate Response After 10 and 15 Minutes of Exercise
Hide Description After baseline vital signs and ECG are recorded, patients will be asked to perform a baseline standardized (modified Bruce) exercise protocol. Heart rate will be recorded during each stage of the exercise protocol. Patients will be asked to exercise to sub-maximal exertion. After the baseline exercise protocol, patients will be given a single dose of oral atenolol. After a two hour waiting period to allow for peak effect of atenolol, patients will repeat the exercise protocol. The primary study outcome measure will be the difference in pre- and post-atenolol ventricular rate response to exercise. The primary outcome measure will be compared in patients with various polymorphisms in genes that might play a role in the inter-individual response to atenolol.
Time Frame after 10 amd 15 minutes of exercise
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol: Ancestral Alleles Atenolol: Variant Carriers
Hide Arm/Group Description:

Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.

These patients have Ancestral Alleles

Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.

These patients have Variant Carriers

Overall Number of Participants Analyzed 19 19
Mean (95% Confidence Interval)
Unit of Measure: beats per minute
After 10 minutes
-11
(-21.9 to -0.1)
-19.7
(-25.6 to -13.9)
After 15 minutes
-25.5
(-67 to -16.8)
-35.2
(-53.3 to -17.1)
Time Frame during study visit, 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atenolol: Ancestral Alleles Atenolol: Variant Carriers
Hide Arm/Group Description

Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.

These patients have Ancestral Alleles

Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.

These patients have Variant Carriers

All-Cause Mortality
Atenolol: Ancestral Alleles Atenolol: Variant Carriers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Atenolol: Ancestral Alleles Atenolol: Variant Carriers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atenolol: Ancestral Alleles Atenolol: Variant Carriers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Matthew Kolek, MD
Organization: Florida Electrophysiology Associates
Phone: (561) 434-0353
EMail: info@heartrhythmexperts.com
Publications:
European Heart Rhythm Association; Heart Rhythm Society, Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Zamorano JL; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol. 2006 Aug 15;48(4):854-906. Erratum in: J Am Coll Cardiol. 2007 Aug 7;50(6):562..
Layout table for additonal information
Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01719367     History of Changes
Other Study ID Numbers: 130298
First Submitted: October 29, 2012
First Posted: November 1, 2012
Results First Submitted: May 22, 2019
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019