Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease

Aortic Valve Stenosis Clinical Trial

Official title:

Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04525937
• Other study ID #: Racial Disparities
• Status: Recruiting
• Start date: June 4, 2018
• Est. completion date: August 1, 2022

Study information

• Verified date: April 2022
• Source: Minneapolis Heart Institute Foundation
• Contact: Sarah Schwager, RN, BSN
• Phone: 612-863-6257
• Email: Sarah.Schwager[@]allina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis
• Constriction, Pathologic
• Disparities in Treatment of Aortic Valve Stenosis

Intervention

Other:
• Patient Questionnaire
Patient Questionnaire
• Provider Questionnaire
Provider Questionnaire

Locations

Country	Name	City	State
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Mortality		30 days and 1 year
Primary	MACE (Major Adverse Cardiac Event)		30 days and 1 year
Secondary	Referring physician- related barriers/biases.	Secondary outcomes (Providers): referring physician-related barriers/biases against routine guideline-driven care for members of disparate groups with severe aortic stenosis.	through study completion, an average of 1 year