Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
NCT ID: NCT06593314
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2025-08-06
2027-06-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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EHR Alert Group
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
Message with EchoGo
This alert will inform the provider that the patient has subclinical HFpEF
Standard Message Group
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
Standard Message
This alert will inform the provider of guideline directed treatment options for patients with diabetes to prevent heart failure.
Interventions
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Message with EchoGo
This alert will inform the provider that the patient has subclinical HFpEF
Standard Message
This alert will inform the provider of guideline directed treatment options for patients with diabetes to prevent heart failure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Echocardiogram available in last 6-months.
Exclusion Criteria
* Not eligible for prescription of new GLP-1RA or SGLT2i or ns-MRA
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Ambarish Pandey
Associate Professor
Principal Investigators
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Ambarish Pandey, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Ambarish Pandey, MD,MSCS
Role: primary
Other Identifiers
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STU-2024-0209
Identifier Type: -
Identifier Source: org_study_id
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