EchoGo-guided alerts to identify and prevent heart failure in people with type 2 diabetes
Identifying Undiagnosed HFpEF Among Patients With Type 2 Diabetes Using Ultromics AI HFpEF Algorithm
NA · University of Texas Southwestern Medical Center · NCT06593314
This project will test if giving doctors EchoGo algorithm results and EHR alerts leads to more guideline-recommended heart-failure prevention treatment for people with type 2 diabetes who show signs of HFpEF on a recent echocardiogram.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06593314 on ClinicalTrials.gov |
What this trial studies
Historic echocardiograms in the UT Southwestern EHR will be reanalyzed using the Ultromics EchoGo algorithm to identify subclinical HFpEF among patients with type 2 diabetes and a high WATCH DM score. Providers for patients with a positive EchoGo result will be randomized to receive either an EHR-based clinical decision support alert with EchoGo findings and guideline-based recommendations (including SGLT2i, non‑steroidal MRA, or GLP‑1 RA when appropriate) or a standard message. Investigators will track provider prescribing and care patterns at 3 and 6 months and will monitor downstream heart-failure hospitalizations for 12 months after the alert. The design is pragmatic and embedded in routine clinical workflows to measure real-world impact on prevention care and short-term clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with type 2 diabetes who have a recent (within 6 months) echocardiogram in the UT Southwestern EHR, a high WATCH DM score, no prior history of heart failure, and who are eligible for new SGLT2i, GLP-1RA or ns‑MRA therapy.
Not a fit: Patients with prior heart failure, those without a recent echocardiogram in the system, or those who are not eligible for the recommended medications are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could lead to earlier initiation of guideline therapies and reduce heart-failure hospitalizations in people with type 2 diabetes.
How similar studies have performed: SGLT2 inhibitors, GLP‑1 receptor agonists, and non‑steroidal MRAs have shown benefits for heart-failure outcomes, but using automated EchoGo imaging analysis combined with EHR provider alerts to change prescribing behavior is relatively novel with limited prior trial data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Ambarish Pandey, MD — University of Texas Southwestern Medical Center
- Study coordinator: Ambarish Pandey, MD
- Email: Ambarish.Pandey@UTSouthwestern.edu
- Phone: 617-869-8957
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Diabetes, Subclinical Heart Failure, Electronic Alerts