Study Stopped
Terminated early due to lack of study feasibility and poor patient recruitment
Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)
BAV
1 other identifier
interventional
85
1 country
13
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 patients with bicuspid aortic valve (BAV) disease (aortopathy) reduces the widening (dilatation) of the aorta from its baseline size.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2011
Longer than P75 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2010
CompletedFirst Posted
Study publicly available on registry
September 16, 2010
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
September 18, 2019
CompletedSeptember 18, 2019
August 1, 2019
4.9 years
September 14, 2010
February 20, 2019
August 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Ascending Aorta Size, as Evaluated by MRI
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.
The difference between baseline measures (2012-2013) and Year 3 measure (2015-2016)
Secondary Outcomes (1)
Rate of Change in Ascending Aorta Size Evaluated by Transthoracic Echocardiography (TEE)
The difference between baseline measures (2012-2013) and Year 3 measure (2015-2016)
Study Arms (2)
Atenolol
EXPERIMENTALAtenolol or matching placebo 25 mg up-titrated to 100 mg.
Telmisartan
EXPERIMENTALTelmisartan or matching placebo 40 mg up-titrated to 80mg
Interventions
Atenolol or matching placebo 25 mg up-titrated to 100 mg
Telmisartan or matching placebo 40 mg up-titrated to 80mg.
Eligibility Criteria
You may qualify if:
- Age =\> 18 years
- Men and women with BAV and ascending aorta measuring \> 37mm.
- Written informed consent
You may not qualify if:
- 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
- Ascending aorta measuring ≥ 50mm, requiring prophylactic ascending aorta surgery
- Unable to provide informed consent
- 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
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7, Canada
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Hamilton Health Sciences-General
Hamilton, Ontario, L8L 2X2, Canada
Population Health Research Institute - Coordinating Centre
Hamilton, Ontario, L8L2X2, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Toronto General Hospital/University of Toronto
Toronto, Ontario, Canada
Cité de la Santé de Laval
Laval, Quebec, H7M 3L9, Canada
McGill University Health Centre
Montreal, Quebec, H3A 1A1, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Regina General Hospital
Regina, Saskatchewan, S4P 0W5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Tara McCready, Program Director
- Organization
- Population Health Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Judith Therrien, MD
MdGill University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2010
First Posted
September 16, 2010
Study Start
June 1, 2011
Primary Completion
April 19, 2016
Study Completion
November 1, 2016
Last Updated
September 18, 2019
Results First Posted
September 18, 2019
Record last verified: 2019-08