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Trial record 32 of 116 for:    Atenolol

Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study) (BAV)

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ClinicalTrials.gov Identifier: NCT01202721
Recruitment Status : Terminated (Terminated early due to lack of study feasibility and poor patient recruitment)
First Posted : September 16, 2010
Results First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Cardiac Disease
Interventions Drug: Atenolol
Drug: Telmisartan
Enrollment 85
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atenolol Telmisartan Atenolol Placebo Telmisartan Placebo
Hide Arm/Group Description Atenolol 25 mg up-titrated to 100 mg. Telmisartan 40 mg up-titrated to 80mg Participants in Atenolol group, randomized to receive matching placebo Participants in Telmisartan group, randomized to receive matching placebo
Period Title: Overall Study
Started 18 26 14 27
Completed 18 26 14 27
Not Completed 0 0 0 0
Arm/Group Title Atenolol Telmisartan Atenolol Placebo Telmisartan Placebo Total
Hide Arm/Group Description Atenolol 25 mg up-titrated to 100 mg. Telmisartan 40 mg up-titrated to 80mg Participants randomized to receive Atenolol placebo Participants randomized to receive Telmisartan placebo Total of all reporting groups
Overall Number of Baseline Participants 18 26 14 27 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 26 participants 14 participants 27 participants 85 participants
43.4  (12.8) 47  (12.2) 49.1  (13.6) 49.1  (11.2) 47.3  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 26 participants 14 participants 27 participants 85 participants
Female
5
  27.8%
7
  26.9%
8
  57.1%
7
  25.9%
27
  31.8%
Male
13
  72.2%
19
  73.1%
6
  42.9%
20
  74.1%
58
  68.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 26 participants 14 participants 27 participants 85 participants
South Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  11.1%
1
   3.8%
1
   7.1%
0
   0.0%
4
   4.7%
Black African
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.7%
1
   1.2%
European
15
  83.3%
23
  88.5%
12
  85.7%
26
  96.3%
76
  89.4%
Native North American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other
1
   5.6%
2
   7.7%
1
   7.1%
0
   0.0%
4
   4.7%
1.Primary Outcome
Title Change From Baseline in Ascending Aorta Size, as Evaluated by MRI
Hide Description 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.
Time Frame The difference between baseline measures (2012-2013) and Year 3 measure (2015-2016)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Atenolol Telmisartan Atenolol Placebo Telmisartan Placebo
Hide Arm/Group Description:
Atenolol 25 mg up-titrated to 100 mg.
Telmisartan 40 mg up-titrated to 80mg
Participants randomized to receive atenolol placebo
Participants randomized to receive telmisartan placebo
Overall Number of Participants Analyzed 16 23 13 25
Mean (Standard Deviation)
Unit of Measure: centimeters squared
.6  (1.4) .4  (1.3) .7  (.8) 1  (1.6)
2.Secondary Outcome
Title Rate of Change in Ascending Aorta Size Evaluated by Transthoracic Echocardiography (TEE)
Hide Description 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.
Time Frame The difference between baseline measures (2012-2013) and Year 3 measure (2015-2016)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Atenolol Telmisartan Atenolol Placebo Telmisartan Placebo
Hide Arm/Group Description:
Atenolol 25 mg up-titrated to 100 mg.
Telmisartan 40 mg up-titrated to 80mg
Participants randomized to receive Atenolol placebo
Participants randomized to receive Telmisartan placebo
Overall Number of Participants Analyzed 17 21 12 23
Mean (Standard Deviation)
Unit of Measure: centimetres squared
-.9  (3.2) -.2  (4.5) -1.6  (4.3) .3  (2.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atenolol Telmisartan Atenolol Placebo Telmisartan Placebo
Hide Arm/Group Description Atenolol 25 mg up-titrated to 100 mg. Telmisartan 40 mg up-titrated to 80mg Participants randomized to receive atenolol placebo Participants randomized to receive telmisartan placebo
All-Cause Mortality
Atenolol Telmisartan Atenolol Placebo Telmisartan Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/26 (0.00%)   0/14 (0.00%)   0/27 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Atenolol Telmisartan Atenolol Placebo Telmisartan Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   2/26 (7.69%)   1/14 (7.14%)   2/27 (7.41%) 
General disorders         
Unexpected Serious Adverse Event  [1]  0/18 (0.00%)  2/26 (7.69%)  1/14 (7.14%)  2/27 (7.41%) 
Indicates events were collected by systematic assessment
[1]
The adverse events were determined not unexpected and not related to study medication. They were related to serious but expected progression of disease or medical history. Specific organ system and adverse term event not specified in outcome analysis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atenolol Telmisartan Atenolol Placebo Telmisartan Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/18 (55.56%)   13/26 (50.00%)   10/14 (71.43%)   18/27 (66.67%) 
Cardiac disorders         
Chest Pain   3/18 (16.67%)  3/26 (11.54%)  1/14 (7.14%)  2/27 (7.41%) 
Shortness of Breath   3/18 (16.67%)  1/26 (3.85%)  1/14 (7.14%)  4/27 (14.81%) 
Investigations         
Other  [1]  1/18 (5.56%)  3/26 (11.54%)  4/14 (28.57%)  7/27 (25.93%) 
Vascular disorders         
Dizziness   3/18 (16.67%)  6/26 (23.08%)  4/14 (28.57%)  4/27 (14.81%) 
Syncope   0/18 (0.00%)  0/26 (0.00%)  0/14 (0.00%)  1/27 (3.70%) 
Indicates events were collected by systematic assessment
[1]
Other issues not listed
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. Tara McCready, Program Director
Organization: Population Health Research Institute
EMail: tara.mccready@phri.ca
Layout table for additonal information
Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01202721     History of Changes
Other Study ID Numbers: BAV-15JUNE2010
First Submitted: September 14, 2010
First Posted: September 16, 2010
Results First Submitted: February 20, 2019
Results First Posted: September 18, 2019
Last Update Posted: September 18, 2019