Disparities in Treatment of Aortic Valve StenosisNCT04525937
Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease
An observational study of Disparities in Treatment of Aortic Valve Stenosis and Aortic Valve Stenosis, run by Minneapolis Heart Institute Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disparities in Treatment of Aortic Valve Stenosis, Aortic Valve Stenosis
- What is being tested?
- Patient Questionnaire and Provider Questionnaire
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age < 18
- Patients who do not allow their records to be used for research
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Mario Goessl, MD, PhD, 612-863-3833, mario.goessl@allina.com
About this study
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.
- Being tested
- Patient Questionnaire, Provider Questionnaire
- Keywords
- Aortic Valve Stenosis, Disparities
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient QuestionnaireOther
Patient Questionnaire
Provider QuestionnaireOther
Provider Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patients with Severe Aortic Stenosis with Disparities | Patients will complete a survey and their aortic stenosis will be clinically followed at 30 days and one year Receives: Other: Patient Questionnaire | |
| Medical Providers with Disparities | Referring primary care providers complete a questionnaire on their referral practices for patients with severe aortic stenosis Receives: Other: Provider Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Mortality
Measured: 30 days and 1 year
MACE (Major Adverse Cardiac Event)
Measured: 30 days and 1 year
Secondary outcomes (1)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start4 Jun 2018
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disparities in Treatment of Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Goessl, MD, PhD, Principal investigator, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525937
- Sponsor's protocol ID
- Racial Disparities
- Status last verified
- Apr 2022
- First submitted
- 20 Aug 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease
- ClinicalTrials.gov ID
- NCT04525937
- Acronym / sponsor ID
- Racial Disparities
- Keywords
- Aortic Valve Stenosis, Disparities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Severe Aortic Stenosis with Disparities | – | Other: Patient QuestionnairePatients will complete a survey and their aortic stenosis will be clinically followed at 30 days and one year |
| Medical Providers with Disparities | – | Other: Provider QuestionnaireReferring primary care providers complete a questionnaire on their referral practices for patients with severe aortic stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age < 18
- Patients who do not allow their records to be used for research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient QuestionnairePatient Questionnaire | Other | Patients with Severe Aortic Stenosis with Disparities |
| Provider QuestionnaireProvider Questionnaire | Other | Medical Providers with Disparities |
Primary outcome
Patient Mortality
Time frame: 30 days and 1 year
MACE (Major Adverse Cardiac Event)
Time frame: 30 days and 1 year
1 secondary outcome
Referring physician- related barriers/biases.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Goessl, MD, PhD principal investigator
Minneapolis Heart Institute Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disparities in Treatment of Aortic Valve Stenosis and Aortic Valve Stenosis, run by Minneapolis Heart Institute Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Schwager, RN, BSN (612-863-6257, Sarah.Schwager@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Mortality (time frame: 30 days and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.