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

NCT06593314 | Recruiting

• 1 other identifier: STU-2024-0209
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Diabetes

Keywords

Subclinical Heart Failure; Electronic Alerts; Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Frequency of prescription of ns-MRA at outpatient clinic visits

  6-months

• Frequency of prescription of GLP-1 RA medication at outpatient clinic visits over

  6 months follow-up

• Heart Failure hospitalization

  12 months

Study Arms (2)

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

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

Behavioral: Standard Message

Interventions

Message with EchoGo BEHAVIORAL

This alert will inform the provider that the patient has subclinical HFpEF

Also known as: EchoGo Message

EHR Alert Group

Standard Message BEHAVIORAL

This alert will inform the provider of guideline directed treatment options for patients with diabetes to prevent heart failure.

Standard Message Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with diagnosis of Type 2 diabetes and High WATCH DM score.
• Echocardiogram available in last 6-months.
• History of HF
• Not eligible for prescription of new GLP-1RA or SGLT2i or ns-MRA

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ambarish Pandey, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ambarish Pandey, MD

CONTACT

617-869-8957; Ambarish.Pandey@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: August 6, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)