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Bicuspid Valve Aortopathy Feasibility Study

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ClinicalTrials.gov Identifier: NCT01920815
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : September 19, 2018
Sponsor:
Collaborators:
Emory University
University of Colorado, Denver
Baylor College of Medicine
University of California, Los Angeles
Penn State University
Information provided by (Responsible Party):
Craig Broberg, Oregon Health and Science University

Brief Summary:
In order to determine the effectiveness of medical therapy options to prevent enlargement of the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This feasibility study will gather accurate data on number needed to screen, changes in medication use over time, and variance of the intended study endpoint.

Condition or disease Intervention/treatment
Bicuspid Aortic Valve Other: No interventions

Detailed Description:
The study will consider all patients with a bicuspid aortic valve and 1) determine the number of patients needed to be screened for a clinical trial, based on patient eligibility percentages applying specific inclusion and exclusion criteria, 2) for those meeting these criteria, follow changes in and compliance with medical therapy over two years, and 3) in a limited subset of eligible patients, perform MRI at baseline and after 2 years to measure the change in aortic area over time.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study
Actual Study Start Date : July 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : October 4, 2017

Group/Cohort Intervention/treatment
Beta blocker therapy
Cohort will consist of those actively taking any beta blocker medication. Observation only.
Other: No interventions
Other Name: Observation only

ARB therapy
Cohort will consist of those actively taking any angiotensin receptor blocker medication. Observation only.
Other: No interventions
Other Name: Observation only

No therapy
Cohort will consist of those not taking either beta blocker nor angiotensin receptor blocker. Observation only.
Other: No interventions
Other Name: Observation only




Primary Outcome Measures :
  1. Change in aortic area measured by MRI [ Time Frame: 24 months ]
    Patients will have a baseline and follow up MRI per a specific protocol to measure area of the ascending thoracic aorta. All measurements will be performed by a core imaging lab


Secondary Outcome Measures :
  1. Clinical events involving the aorta, including change in medical therapy [ Time Frame: 24 months ]
    We will observe for any major clinical events over time such as need for surgery, as well as changes in medical therapy over time.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a bicuspid aortic valve.
Criteria

Inclusion Criteria:

  • Bicuspid aortic valve
  • Aortic measurement of 35 - 49 mm on prior imaging study

Exclusion Criteria:

  • Prior aortic valve or thoracic aortic surgery
  • Prior aortic dissection
  • Other condition associated with enlarged aorta including Coarctation, Marfans, Turner syndrome, Loeys-Dietz, etc.
  • Severe aortic stenosis or regurgitation
  • Contraindication to MRI such as claustrophobia or implanted pacer/defibrillator
  • Anticipated pregnancy, surgery, or move outside the area within 2 years

Information from the National Library of Medicine

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): NCT01920815


Locations
United States, California
University of California
Los Angeles, California, United States
United States, Colorado
University of Colorado
Denver, Colorado, United States
United States, Georgia
Emory University
Atlanta, Georgia, United States
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State
Hershey, Pennsylvania, United States
United States, Texas
Baylor College of Medicine
Houston, Texas, United States
Sponsors and Collaborators
Oregon Health and Science University
Emory University
University of Colorado, Denver
Baylor College of Medicine
University of California, Los Angeles
Penn State University

Responsible Party: Craig Broberg, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01920815     History of Changes
Other Study ID Numbers: 1R34HL115032-01A1--BAV
OHSU IRB 8330
1R34HL115032-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Adrenergic beta-Antagonists
Angiotensin Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs