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Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT02624934
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Baylor University
Information provided by (Responsible Party):
Daniel Katz, Bassett Healthcare

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.

Condition or disease
Aortic Valve Stenosis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Predictive Value of Podocan and Wnt Pathway Regulatory Molecules on Maladaptive Left Ventricular Response in Aortic Stenosis
Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Podocan level [ Time Frame: Day 1 ]
    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 .

  2. Wnt Pathway molecule levels [ Time Frame: Day 1 ]
    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


Secondary Outcome Measures :
  1. Podocan level [ Time Frame: 18 months ]
    Any previously evaluated participants who go on to have aortic valve replacement surgery, will have repeat blood sampling for Podocan levels at time of 9-12 month post op assessment.

  2. Wnt Pathway molecule levels [ Time Frame: 18 months ]
    Any previously evaluated participants who go on to have aortic valve replacement surgery, will have repeat blood sampling for Wnt pathway molecule levels at time of 9-12 month post op assessment.

  3. 6 minute walk test [ Time Frame: Day 1 ]
    To assess whether circulatory podocan is associated with improved functional capacity of patients with AS, the relationship between circulatory podocan and a six minute walk test conducted at the time of cardiac MRI will be assessed



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with know severe aortic stenosis who are scheduled for cardiac MRI
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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): NCT02624934


Contacts
Contact: jennifer Victory, RN 6075471929 jennifer.victory@bassett.org
Contact: Patricia Escaler, MD 6075476911 patricia.escaler@bassett.org

Locations
United States, New York
Bassett Healthcare Network Recruiting
Cooperstown, New York, United States, 13326
Contact: Jennifer Victory, RN    607-547-6965    jennifer.victory@bassett.org   
Contact: Patricia escaler, MD    607-547-3360    patricia.escaler@bassett.org   
Principal Investigator: Daniel Katz, MD         
Sub-Investigator: Abdullah Shahid, MBBS         
Sponsors and Collaborators
Bassett Healthcare
Baylor University
Investigators
Principal Investigator: D Katz, MD Bassett Healthcare

Responsible Party: Daniel Katz, Attending Physician - Cardiology, Bassett Healthcare
ClinicalTrials.gov Identifier: NCT02624934     History of Changes
Other Study ID Numbers: 2023
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Ventricular Remodeling
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction