Platelet Adhesion in the Pathobiology of Aortic Stenosis

Overseen By Jonathan Lindner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Must be taking: Antihypertensives

Disqualifiers: Severe valve disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

65 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria For AS group

Age >25 years of age

Age and sex-matched control subjects undergoing echocardiography with no aortic stenosis, and no more than mild severity disease of other valves.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants undergo advanced imaging and vascular biology studies to assess von Willebrand factor and platelet adhesion

4 years

Regular visits for imaging and blood tests

Follow-up

Participants are monitored for safety and effectiveness after the observation period

6 months

Treatment Details

Interventions

• DiagnosticTest

Participant Groups

Group I: Mild to moderate AS Experimental Treatment 1 Intervention

Patients with mild to moderate AS by echocardiography

Group II: Controls Experimental Treatment 1 Intervention

Age and sex match controls with no AS by echocardiography

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+