Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study) (BAV)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)|
- Change from baseline in ascending aorta size, as evaluated by MRI [ Time Frame: Baseline, Year 3, Year 5 ] [ Designated as safety issue: No ]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 baseline, 3 years and 5 years.
- Rate of change in ascending aorta size evaluated by transthoracic echocardiography (TEE). [ Time Frame: Baseline, Year 1, year 2, Year 3, Year 4 and Final ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Study Completion Date:||August 2016|
|Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|