Platelet Adhesion in the Pathobiology of Aortic Stenosis

Recruiting

• Conditions: Aortic Valve Stenosis
• Interventions: Diagnostic Test: Echocardiogaphy

• Registration Number: NCT05550896
• Lead Sponsor: University of Virginia

Brief Summary

Aortic stenosis (AS) is a serious and common condition that affects 2-3% of the population \>65 years of age in Western countries. It is also responsible for extraordinarily high healthcare expenditures, estimated to be over $6 billion annually,2 in part because the primary treatment for severe AS is aortic valve replacement (AVR) which is resource-intensive. Valve abnormalities are frequently recognized before AS becomes severe, or before there is need for guideline-directed procedural intervention, thereby providing an opportunity for pharmacologic intervention to slow disease progression. Yet, all attempts to prevent AS progression in those with degenerative non-congenital forms of disease have failed. The only non-procedural intervention that benefits patients with moderate or greater AS is the aggressive treatment of hypertension, which reduces net left ventricular (LV) afterload (valvulo-arterial impedance \[Zva\]) and can slow secondary LV remodeling. The overall goal of this proposal is to integrate advanced imaging and vascular biology to study how von Willebrand factor (VWF) and platelet adhesion promote AS progression through many parallel pathways, thereby representing a potential therapeutic target. We are hypothesizing that blood markers of abnormal VWF proteolysis and platelet-derived factors, and abnormal valve shear patterns which can be detected by advanced analysis of spectral Doppler on echocardiography are predictors for progressive AS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Study Start: 2023-01-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-21
• Primary Completion: 2027-08-30
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild to moderate AS	Echocardiogaphy	Patients with mild to moderate AS by echocardiography
Controls	Echocardiogaphy	Age and sex match controls with no AS by echocardiography

Primary Outcome Measures

Name	Time	Method
Evidence for High Shear Patterns on Echocardiography	4 years	Low-amplitude high velocity signals on spectral Doppler

Secondary Outcome Measures

Name	Time	Method
Plasma markers of VWF	4 years	Plasma markers including VWF antigen, oxidation, cleavage; and ADAMTS13 activity

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States