Aortic StenosisDETECT ASNCT05230225
Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: The DETECT AS Trial
A study testing Physician Notification Letter in people with Aortic Stenosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The DETECT AS Trial is a randomized clinical trial and quality improvement initiative that seeks to investigate the impact of electronic provider notification of severe aortic stenosis (AS) on its management, on the utilization of aortic valve replacement (AVR), and on ethnic and racial disparities in AVR utilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Physician Notification Letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 940 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 15 Feb 2026
- Phase
- Interventional
- 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
Who may be able to join
- Subjects with severe aortic stenosis having an aortic valve area of less than or equal to 1.0cm2.
Who cannot join
- Subjects with bioprosthetic or mechanical valves in the aortic position
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
SELMARIAH@mgh.harvard.edu
VTANGUTURI@PARTNERS.ORG
About this study
The DETECT AS Trial is a randomized clinical trial and quality improvement initiative that seeks to investigate the impact of electronic provider notification of severe aortic stenosis (AS) on its management, on the utilization of aortic valve replacement (AVR), and on ethnic and racial disparities in AVR utilization.
After the investigators identify patients in whom echocardiography shows severe aortic stenosis, defined by an aortic valve area (AVA) <1.0cm2, the ordering provider of the echocardiogram will then be randomly assigned to either the intervention group or to the control group. Providers randomly assigned to the intervention group will be sent an electronic (email or message via the electronic health record) physician notification for every one of their patients with severe aortic stenosis on TTE. Electronic notification will also highlight relevant ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS. No intervention will be performed for patients belonging to physicians assigned to the control group.
Read more
The primary endpoint will be AVR utilization, defined as the proportion of patients with a clinical indication for severe AS that undergo AVR. Clinical indications will be based upon the 2020 AHA/ACC Clinical Practice Guidelines for Valvular Heart Disease.
Secondary end-points will be mortality, heart failure hospitalization, TTE utilization/surveillance, AS billing code diagnosis, and cardiology/Heart Valve Team referral. Pre-defined subgroup analyses will be performed to assess AVR utilization among women, racial/ethnic minority groups, low-gradient AS, cardiologist and non-cardiologist ordering provider, and inpatient and outpatient practice settings.
- Conditions
- Aortic Stenosis
- Being tested
- Physician Notification Letter
- Keywords
- Aortic Valve Stenosis, Aortic Valve Disease, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Aortic Valve Replacement
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Disease, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician Notification LetterBehavioural
Receiving the electronic Physician Notification Letter to highlight echocardiography results that are consistent with or may be consistent with severe AS and to be reminded of ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS.
| Study group | Role | What they receive |
|---|---|---|
| Notification Letter Arm | Experimental | Providers that will receive an electronic Physician Notification Letter. Receives: Behavioral: Physician Notification Letter |
| Control Group | No intervention | Providers that will not be contacted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS
Determining whether an electronic physician notification letter improves recognition and management of severe AS through its impact on the utilization of aortic valve replacement, which is defined as the proportion of patients with a clinical indication for severe AS that undergo AVR. We will utilize electronic notification letter to highlight TTE results that are consistent with or may be consistent with severe AS and providers will also be reminded of ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS.
Measured: 1 year
Secondary outcomes (4)
Impact on mortality rate
Establishing the mortality rate among patients with severe AS followed until one year after symptom onset. Using data analysis we will investigate the impact of physician notification letters on recognition and management of AS based on it's effect on mortality rate.
Measured: 1 year
Impact on rate of heart failure hospitalization
Determining the rate of heart failure hospitalizations among patients with severe AS followed until one year after symptom onset. Using data analysis we will investigate the impact of physician notification letters on recognition and management of AS based on it's effect on likelihood of heart failure hospitalization.
Measured: 1 year
Impact on rate of trans-thoracic echocardiogram utilization and frequency of surveillance
Identifying all trans-thoracic echocardiograms ordered by physicians for patients with severe AS until one year after symptom onset in order to Investigate the impact of physician notification letters on the number of follow up echocardiograms ordered and the frequency of surveillance.
Measured: 1 year
Impact on proportion of patients referred to Cardiology/Heart Valve Team
Determining when patients with severe AS get referred to a Cardiology/Heart valve team. Providers receive physician notification letters detailing ACC/AHA Clinical Practice Guideline Recommendations that suggest patients with severe valvular heart disease should be evaluated by a Multidisciplinary Heart Valve Team when intervention is considered. Using data analysis we will investigate the impact of physician notification letters on rate of referral and time to referral to a Cardiology/Heart Valve Team.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start9 Feb 2022
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 940 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Sammy Elmariah, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230225
- Sponsor's protocol ID
- 2022P000016
- Acronym
- DETECT AS
- Status last verified
- Apr 2022
- First submitted
- 13 Jan 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanguturi VK, Abou-Karam R, Cheng F, Duan R, Inglessis-Azuaje I, Langer NB, Yucel EN, Passeri JJ, Hung JW, Elmariah S. Electronic Provider Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: A Randomized Clinical Trial. Circulation. 2025 May 27;151(21):1498-1507. doi: 10.1161/CIRCULATIONAHA.125.074470. Epub 2025 Mar 30.
PubMed 40159132Abou-Karam R, Tanguturi V, Cheng F, Elmariah S. Electronic physician notification to facilitate the recognition and management of severe aortic stenosis: Rationale, design, and methods of the randomized controlled DETECT AS trial. Am Heart J. 2024 Oct;276:39-48. doi: 10.1016/j.ahj.2024.06.009. Epub 2024 Jun 29.
PubMed 38950668
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: The DETECT AS Trial
- ClinicalTrials.gov ID
- NCT05230225
- Acronym / sponsor ID
- DETECT AS / 2022P000016
- Conditions
- Aortic Stenosis
- Keywords
- Aortic Valve Stenosis, Aortic Valve Disease, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 940 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 8 Feb 2022 (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.
The DETECT AS Trial is a randomized clinical trial and quality improvement initiative that seeks to investigate the impact of electronic provider notification of severe aortic stenosis (AS) on its management, on the utilization of aortic valve replacement (AVR), and on ethnic and racial disparities in AVR utilization.
After the investigators identify patients in whom echocardiography shows severe aortic stenosis, defined by an aortic valve area (AVA) <1.0cm2, the ordering provider of the echocardiogram will then be randomly assigned to either the intervention group or to the control group. Providers randomly assigned to the intervention group will be sent an electronic (email or message via the electronic health record) physician notification for every one of their patients with severe aortic stenosis on TTE. Electronic notification will also highlight relevant ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS. No intervention will be performed for patients belonging to physicians assigned to the control group.
The primary endpoint will be AVR utilization, defined as the proportion of patients with a clinical indication for severe AS that undergo AVR. Clinical indications will be based upon the 2020 AHA/ACC Clinical Practice Guidelines for Valvular Heart Disease.
Secondary end-points will be mortality, heart failure hospitalization, TTE utilization/surveillance, AS billing code diagnosis, and cardiology/Heart Valve Team referral. Pre-defined subgroup analyses will be performed to assess AVR utilization among women, racial/ethnic minority groups, low-gradient AS, cardiologist and non-cardiologist ordering provider, and inpatient and outpatient practice settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Notification Letter Arm | Experimental | Behavioral: Physician Notification LetterProviders that will receive an electronic Physician Notification Letter. |
| Control Group | No intervention | –Providers that will not be contacted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with severe aortic stenosis having an aortic valve area of less than or equal to 1.0cm2.
Key exclusion criteria (1 listed)
- Subjects with bioprosthetic or mechanical valves in the aortic position
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 |
|---|---|---|
| Physician Notification LetterReceiving the electronic Physician Notification Letter to highlight echocardiography results that are consistent with or may be consistent with severe AS and to be reminded of ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS. | Behavioural | Notification Letter Arm |
Primary outcome
Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS
Time frame: 1 year
Determining whether an electronic physician notification letter improves recognition and management of severe AS through its impact on the utilization of aortic valve replacement, which is defined as the proportion of patients with a clinical indication for severe AS that undergo AVR. We will utilize electronic notification letter to highlight TTE results that are consistent with or may be consistent with severe AS and providers will also be reminded of ACC/AHA Clinical Practice Guideline recommendations regarding the management of severe AS.
4 secondary outcomes
Impact on mortality rate
Time frame: 1 year
Impact on rate of heart failure hospitalization
Time frame: 1 year
Impact on rate of trans-thoracic echocardiogram utilization and frequency of surveillance
Time frame: 1 year
Impact on proportion of patients referred to Cardiology/Heart Valve Team
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 40159132Tanguturi VK, Abou-Karam R, Cheng F, Duan R, Inglessis-Azuaje I, Langer NB, Yucel EN, Passeri JJ, Hung JW, Elmariah S. Electronic Provider Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis: A Randomized Clinical Trial. Circulation. 2025 May 27;151(21):1498-1507. doi: 10.1161/CIRCULATIONAHA.125.074470. Epub 2025 Mar 30.
- Derived from this study: PubMed 38950668Abou-Karam R, Tanguturi V, Cheng F, Elmariah S. Electronic physician notification to facilitate the recognition and management of severe aortic stenosis: Rationale, design, and methods of the randomized controlled DETECT AS trial. Am Heart J. 2024 Oct;276:39-48. doi: 10.1016/j.ahj.2024.06.009. Epub 2024 Jun 29.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician Notification Letter in people with Aortic Stenosis, run by Massachusetts General Hospital 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 1 inclusion and 1 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 11 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 Roukoz Abou Karam ((617)-412-1147, raboukaram@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish impact of electronic physician notification letter on the likelihood of AVR utilization for patients with a clinical indication for severe AS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05230225, which also lists 2 linked publications.
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 11 Apr 2022.