Clinical trial NCT06593314: Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Official title: Identifying Undiagnosed HFpEF Among Patients With Type 2 Diabetes Using Ultromics AI HFpEF Algorithm
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Diabetes
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with high risk of heart failure (see inclusion/exclusion) who underwent echocardiography will make up the clinical cohort. Corresponding providers will be enrolled in the clinical trial of a clinical decision support tool.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 alert 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 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. The investigators will assess the practice patterns of providers in response to the EHR-based alert over the study period (6-month follow-up). The investigators will also assess the downstream hospitalization events for HF within 12 months of the initial alert.

No Intervention: Control Group providers in the control group will not receive risk information, the computer program will not issue an on-screen alert. 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 6 months and medication listed in the active prescription medication list.

Eligibility criteria: Clinical cohort inclusion exclusion critria:

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
* Active SGLT2-inhibitor use.
* Active GLP1-RA use.
* No echocardiogram within 6-months.

Corresponding providers to patients identified by the above inclusion exclusion criteria will be included in the clinical trial of the decision support tool.

Primary outcomes:
measure: Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 3 months follow-up
timeFrame: 3-month follow-up
measure: Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 3 months follow-up
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Frequency of prescription of SGLT-2i medication at outpatient clinic visits
timeFrame: 6-months
measure: Frequency of prescription of GLP-1 RA medication at outpatient clinic visits over
timeFrame: 6 months follow-up
measure: Heart Failure hospitalization
timeFrame: 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Ambarish Pandey, MD
role: PRINCIPAL_INVESTIGATOR
References: