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Clinical Decision Support for Heart Failure Risk in Diabetes

N/A

Waitlist Available

Led By Ambarish Pandey, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with diagnosis of Type 2 diabetes and High WATCH DM score

Must not have

Active GLP1-RA use

Active SGLT2-inhibitor use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use electronic health records to study the effectiveness of providing Ultromics EchoGo analysis results and recommendations for heart failure prevention therapies.

Who is the study for?

This trial is for patients with Type 2 Diabetes who are at risk of developing heart failure. Specific eligibility criteria have not been provided, but typically participants would need to meet certain health conditions and agree to follow the study procedures.

What is being tested?

The trial is testing a new tool called Ultromics EchoGo that works within electronic health records. It analyzes patient data to identify those at high risk of heart failure and suggests treatments to prevent it.

What are the potential side effects?

Since this trial involves a clinical decision support tool rather than medication or invasive procedures, traditional side effects are not expected. However, there may be implications based on the treatment changes suggested by the tool.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Type 2 diabetes with a high WATCH DM score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using GLP1-RA medication.

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I am currently taking SGLT2-inhibitor medication.

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I have a history of heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 3 months follow-up

Secondary study objectives

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

Frequency of prescription of SGLT-2i medication at outpatient clinic visits

Heart Failure hospitalization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EHR Alert GroupExperimental Treatment1 Intervention

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). Providers will have the option for referring for cardiometabolic e-consult to manage HF risk. 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

Group II: Control GroupActive Control1 Intervention

No alert will be provided to providers in the control group. We will monitor the practice pattern in this group as well over the study period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clinical Decision Support

2019

N/A

~37100

0 / 4Eligibility criteria met