Heart FailureNCT06593314
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
A study testing Message with EchoGo and Standard Message in people with Heart Failure and Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
A pragmatic electronic health record (EHR) based randomized controlled trial to evaluate the utility of providing Ultromics EchoGo analysis results and recommendations for HF risk prevention therapies using an EHR embedded clinical decision support tool. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Diabetes
- What is being tested?
- Message with EchoGo and Standard Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2025to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with diagnosis of Type 2 diabetes and High WATCH DM score.
- Echocardiogram available in last 6-months.
Who cannot join
- History of HF
- Not eligible for prescription of new GLP-1RA or SGLT2i or ns-MRA
- Corresponding providers to patients identified by the above inclusion exclusion criteria will be included in the clinical trial of the decision support tool.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75235
Ambarish Pandey, MD,MSCS, 214-645-9762
About this study
Official title: Identifying Undiagnosed HFpEF Among Patients With Type 2 Diabetes Using Ultromics AI HFpEF Algorithm
A pragmatic electronic health record (EHR) based randomized controlled trial to evaluate the utility of providing Ultromics EchoGo analysis results and recommendations for HF risk prevention therapies using an EHR embedded clinical decision support tool.
Read the detailed description
Historic echocardiograms will be analyzed using the Ultromics EchoGo algorithm. For patients that have a positive EchoGO result i.e. HFpEF detected, the provider will get an clinical decision support alert flagging high risk of HFpEF based on randomized assignment.
Experimental: Alert Group Provider will receive a computer-based provider-to-provider message notifying the provider that the patient has subclinical HFpEF as determined by the Ultromics EchoGo algorithm and associated guideline recommendations for the management of these patients. The alert will include guideline-based and standard-of-care recommendations for the use of SGLT-2 inhibitors, non-steroidal MRA, or GLP-1 RA (if obesity is present). The purpose of the alert is to inform the providers about the risk of heart failure and provide them guidance regarding the guideline-recommended standard of care. The providers can choose to provide care as deemed fit based on the information provided. The investigators will assess the practice patterns of providers in response to the EHR-based alert over the study period (3, and 6-month follow-up). The investigators will also assess the downstream hospitalization events for HF within 12 months of the initial alert.
Control arm: Standard Message Providers in the control group will receive a standard message that will recommend either SGLT2i, GLP-1RA, and/or ns-MRA for treatment of diabetes and for prevention of heart failure. This group will not receive any information about the presence of subclinical heart failure detected by the EchoGo algorithm. The investigators will monitor the practice pattern in this group as well over the study period.
Follow Up. Adherence to SGLT-2i and GLP-1 RA medications will be assessed by evaluating the electronic health record and documenting if the patient had a follow-up with a healthcare provider at 3 and 6 months and medication listed in the active prescription medication list.
Sample Size: The investigators plan to enroll 800 anticipated patients using a parallel design with 1:1 allocation and a binary primary endpoint (SGLT2i use). Using a two-sample test for difference in proportions with the normal (Fleiss) approximation, pooled variance without continuity correction, and assuming a control proportion of 30%, α=0.05 (two-sided), and 80% power, an N=800 (400/arm) provides a minimum detectable absolute increase of ~9.4 percentage points (30.0% to 39.4% in the intervention arm). This corresponds to RR = 1.31(95% CI 1.08, 1.59) and Cohen's h = 0.20.
- Conditions
- Heart Failure, Diabetes
- Being tested
- Message with EchoGo, Standard Message
- Keywords
- Subclinical Heart Failure; Electronic Alerts; Diabetes
- Medical subject headings
- Heart Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Message with EchoGoBehavioural
Also called EchoGo Message
This alert will inform the provider that the patient has subclinical HFpEF
Standard MessageBehavioural
This alert will inform the provider of guideline directed treatment options for patients with diabetes to prevent heart failure.
| Study group | Role | What they receive |
|---|---|---|
| EHR Alert Group | Experimental | Provider will receive a computer-based alert notifying them that the patient has subclinical HFpEF as determined by the Ultromics EchoGo algorithm and associated guideline recommendations for the management of these patients. The alert will include guideline-based and standard-of-care recommendations for the use of SGLT-2 inhibitors and/or GLP-1 RA (if obesity is present). The purpose of the alert is to inform the providers about the risk of heart failure and provide them guidance regarding the guideline-recommended standard of care. The providers can choose to provide care as deemed fit based on the information provided Receives: Behavioral: Message with EchoGo |
| Standard Message Group | Active comparator | We will provide a standard message to the provider detailing guideline-recommended medications for type 2 diabetes. This will not contain information about the Ultromics EchoGo algorithm. The providers can choose to provide care as deemed fit based on the information provided Receives: Behavioral: Standard Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 3 months follow-up
Frequency of prescription of SGLT-2i medication at outpatient clinic visits will be measured as the proportion of new prescription for SGLT2inhibitor divided by the number of alerts triggered.
Measured: 3-month follow-up
Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 6 months follow-up
Frequency of prescription of SGLT-2i medication at outpatient clinic visits will be measured as the proportion of new prescription for GLP1 divided by the number of alerts triggered.
Measured: 3-month follow-up
Secondary outcomes (3)
Frequency of prescription of ns-MRA at outpatient clinic visits
Frequency of prescription of ns-MRA at outpatient clinic visits will be measured as the proportion of new prescription for ns-MRA divided by the number of alerts triggered.
Measured: 6-months
Frequency of prescription of GLP-1 RA medication at outpatient clinic visits over
Frequency of prescription of GLP-1 RA medication at outpatient clinic visits over will be measured as the proportion of new prescription for GLP1 divided by the number of alerts triggered.
Measured: 6 months follow-up
Heart Failure hospitalization
Counts of heart failure hospitalization will be recorded form the electronic health record
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Aug 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with high risk of heart failure (see inclusion/exclusion) as detected by the Ultromics EchoGo algorithm will be included. Each patient will be randomized for their provider to get either a standard message or an Echo-Go message.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ambarish Pandey, University of Texas Southwestern Medical Center
- Investigators
- Ambarish Pandey, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593314
- Sponsor's protocol ID
- STU-2024-0209
- Status last verified
- May 2026
- First submitted
- 9 Sep 2024
- Last updated
- 7 May 2026
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Undiagnosed HFpEF Among Patients With Type 2 Diabetes Using Ultromics AI HFpEF Algorithm
- ClinicalTrials.gov ID
- NCT06593314
- Acronym / sponsor ID
- STU-2024-0209
- Conditions
- Heart Failure, Diabetes
- Keywords
- Subclinical Heart Failure; Electronic Alerts; Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
A pragmatic electronic health record (EHR) based randomized controlled trial to evaluate the utility of providing Ultromics EchoGo analysis results and recommendations for HF risk prevention therapies using an EHR embedded clinical decision support tool.
Detailed description
Historic echocardiograms will be analyzed using the Ultromics EchoGo algorithm. For patients that have a positive EchoGO result i.e. HFpEF detected, the provider will get an clinical decision support alert flagging high risk of HFpEF based on randomized assignment.
Experimental: Alert Group Provider will receive a computer-based provider-to-provider message notifying the provider that the patient has subclinical HFpEF as determined by the Ultromics EchoGo algorithm and associated guideline recommendations for the management of these patients. The alert will include guideline-based and standard-of-care recommendations for the use of SGLT-2 inhibitors, non-steroidal MRA, or GLP-1 RA (if obesity is present). The purpose of the alert is to inform the providers about the risk of heart failure and provide them guidance regarding the guideline-recommended standard of care. The providers can choose to provide care as deemed fit based on the information provided. The investigators will assess the practice patterns of providers in response to the EHR-based alert over the study period (3, and 6-month follow-up). The investigators will also assess the downstream hospitalization events for HF within 12 months of the initial alert.
Control arm: Standard Message Providers in the control group will receive a standard message that will recommend either SGLT2i, GLP-1RA, and/or ns-MRA for treatment of diabetes and for prevention of heart failure. This group will not receive any information about the presence of subclinical heart failure detected by the EchoGo algorithm. The investigators will monitor the practice pattern in this group as well over the study period.
Follow Up. Adherence to SGLT-2i and GLP-1 RA medications will be assessed by evaluating the electronic health record and documenting if the patient had a follow-up with a healthcare provider at 3 and 6 months and medication listed in the active prescription medication list.
Sample Size: The investigators plan to enroll 800 anticipated patients using a parallel design with 1:1 allocation and a binary primary endpoint (SGLT2i use). Using a two-sample test for difference in proportions with the normal (Fleiss) approximation, pooled variance without continuity correction, and assuming a control proportion of 30%, α=0.05 (two-sided), and 80% power, an N=800 (400/arm) provides a minimum detectable absolute increase of ~9.4 percentage points (30.0% to 39.4% in the intervention arm). This corresponds to RR = 1.31(95% CI 1.08, 1.59) and Cohen's h = 0.20.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with high risk of heart failure (see inclusion/exclusion) as detected by the Ultromics EchoGo algorithm will be included. Each patient will be randomized for their provider to get either a standard message or an Echo-Go message.
| Arm | Type | Receives |
|---|---|---|
| EHR Alert Group | Experimental | Behavioral: Message with EchoGoProvider will receive a computer-based alert notifying them that the patient has subclinical HFpEF as determined by the Ultromics EchoGo algorithm and associated guideline recommendations for the management of these patients. The alert will include guideline-based and standard-of-care recommendations for the use of SGLT-2 inhibitors and/or GLP-1 RA (if obesity is present). The purpose of the alert is to inform the providers about the risk of heart failure and provide them guidance regarding the guideline-recommended standard of care. The providers can choose to provide care as deemed fit based on the information provided |
| Standard Message Group | Active comparator | Behavioral: Standard MessageWe will provide a standard message to the provider detailing guideline-recommended medications for type 2 diabetes. This will not contain information about the Ultromics EchoGo algorithm. The providers can choose to provide care as deemed fit based on the information provided |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with diagnosis of Type 2 diabetes and High WATCH DM score.
- Echocardiogram available in last 6-months.
Key exclusion criteria (3 listed)
- History of HF
- Not eligible for prescription of new GLP-1RA or SGLT2i or ns-MRA
- Corresponding providers to patients identified by the above inclusion exclusion criteria will be included in the clinical trial of the decision support tool.
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 |
|---|---|---|
| Message with EchoGoAlso: EchoGo MessageThis alert will inform the provider that the patient has subclinical HFpEF | Behavioural | EHR Alert Group |
| Standard MessageThis alert will inform the provider of guideline directed treatment options for patients with diabetes to prevent heart failure. | Behavioural | Standard Message Group |
Primary outcome
Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 3 months follow-up
Time frame: 3-month follow-up
Frequency of prescription of SGLT-2i medication at outpatient clinic visits will be measured as the proportion of new prescription for SGLT2inhibitor divided by the number of alerts triggered.
Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 6 months follow-up
Time frame: 3-month follow-up
Frequency of prescription of SGLT-2i medication at outpatient clinic visits will be measured as the proportion of new prescription for GLP1 divided by the number of alerts triggered.
3 secondary outcomes
Frequency of prescription of ns-MRA at outpatient clinic visits
Time frame: 6-months
Frequency of prescription of GLP-1 RA medication at outpatient clinic visits over
Time frame: 6 months follow-up
Heart Failure hospitalization
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- 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.
Ambarish Pandey, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Message with EchoGo and Standard Message in people with Heart Failure and Diabetes, run by University of Texas Southwestern Medical Center 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ambarish Pandey, MD (617-869-8957, Ambarish.Pandey@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 3 months follow-up (time frame: 3-month follow-up). 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 7 May 2026.