Trial Outcomes & Findings for Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study) (NCT NCT01202721)
NCT ID: NCT01202721
Last Updated: 2019-09-18
Results Overview
The primary analyses include the evaluation of the effects of monotherapy (atenolol vs. placebo, telmisartan vs. placebo) on the change in aortic root size measured at 3 years. Change is measured in centimeters squared (final measurement - baseline measurement). Original outcome measure time frame was scheduled for 5 years, however due to poor study participant and site recruitment study was closed early and final outcome measures taken at approximately 3 years.
TERMINATED
PHASE3
85 participants
The difference between baseline measures (2012-2013) and Year 3 measure (2015-2016)
2019-09-18
Participant Flow
Participant milestones
| Measure |
Atenolol
Atenolol 25 mg up-titrated to 100 mg.
|
Telmisartan
Telmisartan 40 mg up-titrated to 80mg
|
Atenolol Placebo
Participants in Atenolol group, randomized to receive matching placebo
|
Telmisartan Placebo
Participants in Telmisartan group, randomized to receive matching placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
26
|
14
|
27
|
|
Overall Study
COMPLETED
|
18
|
26
|
14
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)
Baseline characteristics by cohort
| Measure |
Atenolol
n=18 Participants
Atenolol 25 mg up-titrated to 100 mg.
|
Telmisartan
n=26 Participants
Telmisartan 40 mg up-titrated to 80mg
|
Atenolol Placebo
n=14 Participants
Participants randomized to receive Atenolol placebo
|
Telmisartan Placebo
n=27 Participants
Participants randomized to receive Telmisartan placebo
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 12.8 • n=39 Participants
|
47 years
STANDARD_DEVIATION 12.2 • n=41 Participants
|
49.1 years
STANDARD_DEVIATION 13.6 • n=35 Participants
|
49.1 years
STANDARD_DEVIATION 11.2 • n=31 Participants
|
47.3 years
STANDARD_DEVIATION 12.3 • n=146 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
27 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
58 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Black African
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
European
|
15 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
76 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Native North American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: The difference between baseline measures (2012-2013) and Year 3 measure (2015-2016)Population: Intention to treat analysis method followed: patients completed final visit over the phone where aortic root size cannot be measured; patients refused a final visit, or patient's information was received through a third party. Patients missing primary outcome measures still followed for other analyses.
The primary analyses include the evaluation of the effects of monotherapy (atenolol vs. placebo, telmisartan vs. placebo) on the change in aortic root size measured at 3 years. Change is measured in centimeters squared (final measurement - baseline measurement). Original outcome measure time frame was scheduled for 5 years, however due to poor study participant and site recruitment study was closed early and final outcome measures taken at approximately 3 years.
Outcome measures
| Measure |
Atenolol
n=16 Participants
Atenolol 25 mg up-titrated to 100 mg.
|
Telmisartan
n=23 Participants
Telmisartan 40 mg up-titrated to 80mg
|
Atenolol Placebo
n=13 Participants
Participants randomized to receive atenolol placebo
|
Telmisartan Placebo
n=25 Participants
Participants randomized to receive telmisartan placebo
|
|---|---|---|---|---|
|
Change From Baseline in Ascending Aorta Size, as Evaluated by MRI
|
.6 centimeters squared
Standard Deviation 1.4
|
.4 centimeters squared
Standard Deviation 1.3
|
.7 centimeters squared
Standard Deviation .8
|
1 centimeters squared
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: The difference between baseline measures (2012-2013) and Year 3 measure (2015-2016)Population: Discrepancy exists between participant flow numbers and patients analyzed for the following reasons: patients completed final visit over the phone where aortic root size cannot be measured; patients refused a final visit, patient's information was received through a third party. Pt's not removed as they are still included in other analyses
Rate of change in ascending aorta size evaluated by transthoracic echocardiography (ECHO) at 3 years. Change is measured in centimeters squared (final measurement - baseline measurement). Time frame was scheduled for 5 years, however due to poor study participant and site recruitment study was closed early and final outcome measures taken at approximately 3 years.
Outcome measures
| Measure |
Atenolol
n=17 Participants
Atenolol 25 mg up-titrated to 100 mg.
|
Telmisartan
n=21 Participants
Telmisartan 40 mg up-titrated to 80mg
|
Atenolol Placebo
n=12 Participants
Participants randomized to receive atenolol placebo
|
Telmisartan Placebo
n=23 Participants
Participants randomized to receive telmisartan placebo
|
|---|---|---|---|---|
|
Rate of Change in Ascending Aorta Size Evaluated by Transthoracic Echocardiography (TEE)
|
-.9 centimetres squared
Standard Deviation 3.2
|
-.2 centimetres squared
Standard Deviation 4.5
|
-1.6 centimetres squared
Standard Deviation 4.3
|
.3 centimetres squared
Standard Deviation 2.8
|
Adverse Events
Atenolol
Telmisartan
Atenolol Placebo
Telmisartan Placebo
Serious adverse events
| Measure |
Atenolol
n=18 participants at risk
Atenolol 25 mg up-titrated to 100 mg.
|
Telmisartan
n=26 participants at risk
Telmisartan 40 mg up-titrated to 80mg
|
Atenolol Placebo
n=14 participants at risk
Participants randomized to receive atenolol placebo
|
Telmisartan Placebo
n=27 participants at risk
Participants randomized to receive telmisartan placebo
|
|---|---|---|---|---|
|
General disorders
Unexpected Serious Adverse Event
|
0.00%
0/18
|
7.7%
2/26
|
7.1%
1/14
|
7.4%
2/27
|
Other adverse events
| Measure |
Atenolol
n=18 participants at risk
Atenolol 25 mg up-titrated to 100 mg.
|
Telmisartan
n=26 participants at risk
Telmisartan 40 mg up-titrated to 80mg
|
Atenolol Placebo
n=14 participants at risk
Participants randomized to receive atenolol placebo
|
Telmisartan Placebo
n=27 participants at risk
Participants randomized to receive telmisartan placebo
|
|---|---|---|---|---|
|
Cardiac disorders
Chest Pain
|
16.7%
3/18
|
11.5%
3/26
|
7.1%
1/14
|
7.4%
2/27
|
|
Cardiac disorders
Shortness of Breath
|
16.7%
3/18
|
3.8%
1/26
|
7.1%
1/14
|
14.8%
4/27
|
|
Vascular disorders
Dizziness
|
16.7%
3/18
|
23.1%
6/26
|
28.6%
4/14
|
14.8%
4/27
|
|
Vascular disorders
Syncope
|
0.00%
0/18
|
0.00%
0/26
|
0.00%
0/14
|
3.7%
1/27
|
|
Investigations
Other
|
5.6%
1/18
|
11.5%
3/26
|
28.6%
4/14
|
25.9%
7/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place