Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis

NCT02624934 | Completed

• 1 other identifier: 2023
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Aortic stenosis is a major cause of morbidity around the world. Progressive aortic stenosis leads to cardiac hypertrophy as a compensatory response. A maladaptive response may lead to heart failure at varying degrees of severity of aortic stenosis in individual patients. The predicting factors for the occurrence of a maladaptive response are not well defined. Therefore current medical therapy for aortic stenosis is considered insufficient and may actually cause harm. The only effective therapy for severe, symptomatic aortic stenosis is aortic valve replacement. It has been found in an experimental study that Podocan determines the degree of cardiac hypertrophy in response to pressure overload via the Wnt-pathway. The possible prognostic role of secreted circulating Wnt modulators in aortic stenosis has also recently gained attention. This project will attempt to establish the prognostic role of circulatory Podocan and Wnt modulators for maladaptive left ventricular response to aortic stenosis. This may help identify patients at particular risk to develop left ventricular dysfunction with aortic stenosis and improve understanding of the mechanisms of left ventricular remodeling in aortic stenosis. Hence, this may also later act as an important background in finding more effective therapies to prevent or delay maladaptive left ventricular response in aortic stenosis.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• Podocan level

  All patients having a cardiac MRI have an IV line placed as normal procedure. When the line has been placed, prior to contrast infusion (if applicable)or other medication administration, blood samples will be collected to test for circulatory Podocan .

  Day 1

• Wnt Pathway molecule levels

  All patients having a cardiac MRI have an IV line placed as normal procedure. When the line has been placed, prior to contrast infusion (if applicable)or other medication administration, blood samples will be collected to test for circulatory Wnt pathway molecules

  Day 1

Secondary Outcomes (3)

• Podocan level

  18 months

• Wnt Pathway molecule levels

  18 months

• 6 minute walk test

  Day 1

Eligibility Criteria

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

Study Population

Patients with know severe aortic stenosis who are scheduled for cardiac MRI

You may qualify if:

• Age 18 or greater
• Scheduled for Cardiac MRI
• Patients with known aortic valve area of less than 1 cm² on echocardiogram
• Able to provide informed consent
• Ambulatory and expected to be able to complete 6 minute walk test

You may not qualify if:

• Other significant (moderate or severe) valvular heart disease
• Unable to complete 6 minute walk test (ex. Wheelchair bound)

Sponsors & Collaborators

• Bassett Healthcare: lead
• Baylor University: collaborator

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• D Katz, MD

  Bassett Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: December 9, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

US (1)