Status:
TERMINATED
Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Population Health Research Institute
Conditions:
Cardiac Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether long-term treatment with a beta-blocker (BB) such as atenolol and/or an angiotensin receptor blocker (ARB) such as telmisartan, given to adult patient...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age =\> 18 years
- Men and women with BAV and ascending aorta measuring \> 37mm.
- Written informed consent
- General Study Exclusion Criteria
- History of cardiac diseases, such as
- Symptomatic aortic stenosis or aortic regurgitation referred for surgical intervention or asymptomatic severe aortic stenosis or regurgitation based on current guidelines
- Uncontrolled heart failure, right ventricular failure due to pulmonary hypertension
- Cardiogenic shock
- Systolic blood pressure \< 100 mmHg
- History of drug sensitivity, contraindication or adverse reaction to both BB and ARB. Participants who are able to tolerate only a BB will be allocated to the BB vs. placebo arm, and participants who are able to tolerate only an ARB will be allocated to the ARB vs. placebo arm, assuming no other exclusion criteria are met.
- Ascending aorta measuring ≥ 50mm, requiring prophylactic ascending aorta surgery
- Unable to provide informed consent
- Need for both BB and ARB for treatment of concomitant medical conditions for which there are no other alternatives. Participants who are taking an ARB which cannot be discontinued will be allocated to the BB arm, and participants who are taking a BB which cannot be discontinued will be allocated to the ARB arm, if no other exclusion criteria are met.
- Prior surgery on ascending aorta or aortic root (balloon valvuloplasty, aortic valvotomy or post coarctation surgery are acceptable)
- Women who are pregnant at screening visit
- Contraindication to MRI (claustrophobia, pacemaker, metallic clip in eye or brain)
- History of any illness which limits the participants' ability to complete the study
- Additional Exclusion Criteria for BB arm only
- Heart rate \<60 bpm
- Heart block (1st, 2nd and 3rd degree AV block on ECG), or sick sinus syndrome
- Asthma of sufficient severity to represent a contraindication to BB use in the judgment of the patient's physician
- History of severe peripheral artery disorders
- History of pheochromocytoma without the use of alpha-adrenergic blockers
- History of metabolic acidosis
- Additional Exclusion Criteria for ARB arm only
- Women who are pregnant, lactating or who intend to become pregnant during the course of the study
- Women who are of childbearing age and are not on reliable, accepted form of birth control
- Hyperkalemia \[serum potassium \> 5.5 mmol/L\] or renal dysfunction \[GFR\<45% measured by MDRD)
- Patients being treated with an ACE Inhibitor that cannot be discontinued. (These patients may be randomized in the BB arm if no exclusion criteria are met.)
- History of bilateral renal artery stenosis or unilateral renal artery stenosis to a solitary kidney
- History of hepatic insufficiency and hepato-biliary obstruction
- History of fructose intolerance
Exclusion
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01202721
Start Date
June 1 2011
End Date
November 1 2016
Last Update
September 18 2019
Active Locations (13)
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1
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada, T6G 2B7
2
University of British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
3
St. Boniface Hospital
Winnipeg, Manitoba, Canada
4
Hamilton Health Sciences-General
Hamilton, Ontario, Canada, L8L 2X2