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

NCT01202721 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2019-09-18

Study results available
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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.

Conditions

  • Cardiac Disease

Interventions

DRUG

Atenolol

Atenolol or matching placebo 25 mg up-titrated to 100 mg

DRUG

Telmisartan

Telmisartan or matching placebo 40 mg up-titrated to 80mg.

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER
  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Judith Therrien, MD · MdGill University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-04-19
Completion
2016-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01202721 on ClinicalTrials.gov