Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Diabetes
• Intervention / Treatment: Behavioral: Message with EchoGo; Behavioral: Standard Message

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 Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ambarish Pandey, MD; Phone Number: 617-869-8957; Email: Ambarish.Pandey@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Ambarish Pandey, MD,MSCS; Phone Number: 214-645-9762

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Clinical cohort inclusion exclusion criteria:

Inclusion Criteria:

• Patients with diagnosis of Type 2 diabetes and High WATCH DM score.
• Echocardiogram available in last 6-months.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Message with EchoGo; This alert will inform the provider that the patient has subclinical HFpEF; Other Names: EchoGo Message
Active Comparator: 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	Behavioral: Standard Message; This alert will inform the provider of guideline directed treatment options for patients with diabetes to prevent heart failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months follow-up
Heart Failure hospitalization	Counts of heart failure hospitalization will be recorded form the electronic health record	12 months
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.	6-months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Ambarish Pandey, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Subclinical Heart Failure; Electronic Alerts; Diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Heart Failure; Diabetes Mellitus
• Other Study ID Numbers: STU-2024-0209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No