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Bicuspid Valve Aortopathy Feasibility Study

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status

Completed

Conditions

Bicuspid Aortic Valve

Treatments

Other: No interventions

Study type

Observational

Funder types

Other

Identifiers

NCT01920815
1R34HL115032-01A1--BAV
OHSU IRB 8330
1R34HL115032-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

500 participants in 3 patient groups

Beta blocker therapy
Description:
Cohort will consist of those actively taking any beta blocker medication. Observation only.
Treatment:
Other: No interventions
ARB therapy
Description:
Cohort will consist of those actively taking any angiotensin receptor blocker medication. Observation only.
Treatment:
Other: No interventions
No therapy
Description:
Cohort will consist of those not taking either beta blocker nor angiotensin receptor blocker. Observation only.
Treatment:
Other: No interventions

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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