Viewing Study NCT06593314



Ignite Creation Date: 2024-10-26 @ 3:40 PM
Last Modification Date: 2024-10-26 @ 3:40 PM
Study NCT ID: NCT06593314
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-09

Brief Title: Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Sponsor: None
Organization: None

Study Overview

Official Title: Identifying Undiagnosed HFpEF Among Patients With Type 2 Diabetes Using Ultromics AI HFpEF Algorithm
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 ie 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 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 andor 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 We will assess the practice patterns of providers in response to the EHR-based alert over the study period 6-month follow-up We 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 We 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None