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
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Disease||Drug: Atenolol Drug: Telmisartan||Phase 3|
Bicuspid aortic valve (BAV) is the most common congenital heart disease lesion with an estimated 280 000 to 560 000 people affected in the Canada. Dilatation of the ascending aorta is a common feature in patients with BAV and is a result of inherent vascular abnormalities with superimposed effects of age and acquired cardiovascular risk factors. Severe aortic dilatation (> 50mm) leads to aortic dissection and premature death.
Histopathological studies of the aortas in patients with BAVs report similar findings to that of patients with Marfan syndrome. Beta Blocker (BB) therapy and more recently, Angiotensin Receptor Blocker (ARB) therapy, have been shown to decrease to rate of aortic dilatation and be of benefit to patients with Marfan syndrome. There is no such data however in patients with BAV and aortopathy.
Within the context of a randomized clinical trial, the investigators proposed to test the hypothesis that BB or ARB will reduce the rate of progressive aortic dilatation in adults with BAVs and ascending aortopathy as compared to placebo.
Design: Multicentre, randomized, double-blind, placebo-controlled, trial of adult patients with bicuspid aortic valve aortopathy. Patients who are eligible to take either study medication will be randomly allocated to participate in either the BB (atenolol) vs. placebo arm, or the ARB (telmisartan) vs. placebo arm. Patients who are ineligible for the BB arm will be assigned to the ARB vs. placebo arm and patients who are ineligible for the ARB arm will be assigned to the BB vs. placebo arm. Within each arm, all participants will be randomized to take either placebo or active medication. The atenolol arm will be up-titrated to100mg/day and the telmisartan arm will be up-titrated to 80 mg/day, or to the maximum tolerated dose.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)|
|Actual Study Start Date :||June 2011|
|Actual Primary Completion Date :||April 19, 2016|
|Actual Study Completion Date :||November 2016|
Atenolol or matching placebo 25 mg up-titrated to 100 mg.
Atenolol or matching placebo 25 mg up-titrated to 100 mg
Telmisartan or matching placebo 40 mg up-titrated to 80mg
Telmisartan or matching placebo 40 mg up-titrated to 80mg.
- Change From Baseline in Ascending Aorta Size, as Evaluated by MRI [ Time Frame: The difference between baseline measures (2012-2013) and Year 3 measure (2015-2016) ]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.
- Rate of Change in Ascending Aorta Size Evaluated by Transthoracic Echocardiography (TEE) [ Time Frame: The difference between baseline measures (2012-2013) and Year 3 measure (2015-2016) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202721
|Mazankowski Alberta Heart Institute|
|Edmonton, Alberta, Canada, T6G 2B7|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|St. Boniface Hospital|
|Winnipeg, Manitoba, Canada|
|Hamilton Health Sciences-General|
|Hamilton, Ontario, Canada, L8L 2X2|
|Population Health Research Institute - Coordinating Centre|
|Hamilton, Ontario, Canada, L8L2X2|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 5A5|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Toronto General Hospital/University of Toronto|
|Toronto, Ontario, Canada|
|Cité de la Santé de Laval|
|Laval, Quebec, Canada, H7M 3L9|
|McGill University Health Centre|
|Montreal, Quebec, Canada, H3A 1A1|
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Centre Hospitalier Universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Regina General Hospital|
|Regina, Saskatchewan, Canada, S4P 0W5|
|Principal Investigator:||Judith Therrien, MD||MdGill University|