Podocan and Wnt Pathway in the Development of Aortopathy in Bicuspid Valve Disease

NCT02806310 | Completed

• 1 other identifier: 2041
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Bicuspid Aortic Valve (BAV) disease is a common cardiac anomaly that is associated with valvular abnormalities, both stenosis and regurgitation, and aortopathy. It is also shown to play role in abnormal aortic distensibility and stiffness with impairment of aortic elasticity and Left ventricular dysfunction. Mechanism of aortopathy is complex and is not understood completely. In a recent study podocan is found in extracellular matrix (ECM) of human aorta and is found to be accumulated in human abdominal aortic aneurysms. There is no current effective therapy that can alter the progression of aortic dilatation in bicuspid valve disease. Aortic surgery and aortoplasty is the only treatment in severely dilated aorta and aortic dissection. In this study the aim is to investigate the association between podocan and Wnt pathway in development and pathogenesis of aortopathy. This could provide more effective and physiological understanding of disease process and potential target in prevention and treatment for aortopathy.

Conditions

Aortic Valve Disease

Keywords

Aortic Valve; Bicuspid

Outcome Measures

Primary Outcomes (2)

• Circulatory podocon levels

  Day 1

• circulatory WNT pathway molecule levels

  Day1

Secondary Outcomes (2)

• podocon expression in aortic tissue

  24 months

• WNT pathway molecule expression in aortic tissue

  24 months

Study Arms (2)

Prospective

Group A: Patients with known BAV who are scheduled to have a cardiac MRI.

Other: Blood draw

Historic

Group B: Patients with known BAV who have already had an MRI within the past year

Other: Blood draw

Interventions

Blood draw OTHER

blood sampling for biomarker levels

Historic; Prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with known BAV.

You may qualify if:

• Age 18 or greater
• Patients with known BAV diagnosed by echocardiography, previous MRI, or cardiac CT
• Scheduled for cardiac MRI or have had a cardiac MRI within the past year
• Able to provide informed consent
• Ambulatory and expected to be able to complete 6 minute walk test

You may not qualify if:

• Patients without BAV
• Patients who have already had surgery for aortic valve problems and/or aortopathy
• Unable to complete 6 minute walk test (ex. Wheelchair bound)

Sponsors & Collaborators

• Bassett Healthcare: lead

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

All patients who do undergo valve replacement or aortic graft surgery within the 24 month follow up period, will have their valve tissue samples analyzed for podocan levels. These tissues are removed as a routine part of the surgery and sent to the clinical laboratory at Bassett. The Bassett Clinical Lab will prepare additional paraffin blocks and slides of the tissue for the research study. Specifically, aortic aneurysm and aortic root tissue will be analyzed. The relationship between cell density (mm2) and Podocan, in addition to the six Wnt molecule levels, will be analyzed.

MeSH Terms

Conditions

Aortic Valve Disease; Bicuspid Aortic Valve Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• daniel Katz, MD

  Bassett Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician - Cardiology

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 20, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)