Trial Outcomes & Findings for Genetically Determined Response to Atenolol in Patients With Persistent Atrial Fibrillation (NCT NCT01719367)
NCT ID: NCT01719367
Last Updated: 2019-06-17
Results Overview
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.
COMPLETED
NA
38 participants
after 5minutes of exercise
2019-06-17
Participant Flow
Participant milestones
| Measure |
Atenolol: Ancestral Alleles
Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.
participants have Ancestral Alleles
|
Atenolol: Variant Carriers
Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.
participants have Variant Carriers
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genetically Determined Response to Atenolol in Patients With Persistent Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
All Participants
n=38 Participants
all participants
|
|---|---|
|
Age, Continuous
|
70.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after 5minutes of exerciseAfter 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.
Outcome measures
| Measure |
Atenolol: Ancestral Alleles
n=19 Participants
Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.
These patients have Ancestral Alleles
|
Atenolol: Variant Carriers
n=19 Participants
Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.
These patients have Variant Carriers
|
|---|---|---|
|
Change in Pre- and Post-atenolol Ventricular Rate Response After 5 Minutes of Exercise
|
-10 beats per minute
Interval -18.6 to -1.4
|
-13 beats per minute
Interval -20.2 to -5.8
|
PRIMARY outcome
Timeframe: after 10 amd 15 minutes of exerciseAfter 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.
Outcome measures
| Measure |
Atenolol: Ancestral Alleles
n=19 Participants
Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.
These patients have Ancestral Alleles
|
Atenolol: Variant Carriers
n=19 Participants
Patients will undergo a standardized, graded exercise protocol before and after receiving a dose of oral atenolol.
These patients have Variant Carriers
|
|---|---|---|
|
Change in Pre- and Post-atenolol Ventricular Rate Response After 10 and 15 Minutes of Exercise
After 10 minutes
|
-11 beats per minute
Interval -21.9 to -0.1
|
-19.7 beats per minute
Interval -25.6 to -13.9
|
|
Change in Pre- and Post-atenolol Ventricular Rate Response After 10 and 15 Minutes of Exercise
After 15 minutes
|
-25.5 beats per minute
Interval -67.0 to -16.8
|
-35.2 beats per minute
Interval -53.3 to -17.1
|
Adverse Events
Atenolol: Ancestral Alleles
Atenolol: Variant Carriers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Matthew Kolek, MD
Florida Electrophysiology Associates
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place