Clinical trial NCT04525937: Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease
Official title: Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disparities in Treatment of Aortic Valve Stenosis
Aortic Valve Stenosis
Keywords: Aortic Valve Stenosis
Disparities
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients:

- Over 18 years of age with echocardiographic diagnosis of severe, symptomatic AS and intermediate to high surgical risk per Society of Thoracic Surgeons (STS) mortality risk-score who have a disparate condition

Providers:

- Referring primary care providers, cardiologists and cardiovascular surgeons at the study sites.

Brief summary: Common barriers to receiving appropriate guideline-driven care for patients with severe aortic stenosis include referral biases by primary care providers (lack of provider education), patient comorbidities (degree of fragility), as well as psychosocial issues and cultural barriers. Additionally, race, ethnicity, socioeconomic status (SES) and education level are shown to be persistent barriers to accessing healthcare services and healthcare systems, creating a significant practice gap between various patient populations. The most recent transcatheter valve therapies (TVT) registry data show that \>94% of TAVR recipients are Caucasian, followed by less than 4% of African-Americans and Hispanics, respectively. There is a critical need to understand the barriers to treatment and care among severe aortic valve disease patients of disparate groups. This study is a multi-center, retrospective and prospective cohort study of patients diagnosed with severe aortic stenosis. Additionally, we will be surveying referring primary care providers, cardiologists and cardiovascular surgeons to assess their current referral practices for patients with severe aortic stenosis.


Eligibility criteria: Inclusion Criteria:

* Disparity/Diversity background (either race/ethnicity, low SES (adults with incomes at or below the federal poverty level (family income to poverty ratio, ≤1), language (non-English speaker) or education (≤9 years of education))
* Patient scheduled for transcatheter aortic valve replacement using the Edwards Sapien valve, OR recently implanted with Edwards Sapien valve (up to 1 year post-TAVR)
* Echocardiographic diagnosis of severe, symptomatic AS and intermediate to high surgical risk per Society of Thoracic Surgeons (STS) mortality risk-score

Exclusion Criteria:

* Age \< 18
* Patients who do not allow their records to be used for research

Primary outcomes:
measure: Patient Mortality
timeFrame: 30 days and 1 year
measure: MACE (Major Adverse Cardiac Event)
timeFrame: 30 days and 1 year
Secondary outcomes:
measure: Referring physician- related barriers/biases.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
Study officials:
affiliation: Minneapolis Heart Institute Foundation
name: Mario Goessl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: