Clinical Decision Support for Heart Failure Risk in Diabetes

Overseen By Vinayak Subramanian

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: SGLT2-inhibitors, GLP1-RAs

Disqualifiers: History of HF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently using SGLT2-inhibitors or GLP1-RA medications, you will need to stop taking them to participate in this trial.

How is the treatment for heart failure risk in diabetes unique?

The treatment is unique because it involves a clinical decision support system that uses a combination of clinical data, electrocardiogram (a test that records the heart's electrical activity), NTproBNP (a blood test that measures heart stress), and echocardiogram (an ultrasound of the heart) to identify diabetes patients at risk for heart failure, which is not a standard approach in current practice. ^{1 2 3 4 5}

Who Is on the Research Team?

Ambarish Pandey, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Echocardiogram available in last 6-months

Exclusion Criteria

I am currently using GLP1-RA medication.

I am currently taking SGLT2-inhibitor medication.

No echocardiogram within 6-months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Providers receive alerts for patients with subclinical HFpEF, guiding them on standard-of-care recommendations

6 months

Ongoing monitoring through EHR

Follow-up

Adherence to SGLT-2i and GLP-1 RA medications assessed, and heart failure hospitalization events monitored

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Ultromics EchoGo HFpEF Algorithm

Trial Overview 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.

How Is the Trial Designed?

Group I: EHR Alert Group Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Management of patients with diabetes and heart failure with reduced ejection fraction: An international comparison. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Comorbidities and their implications in patients with and without type 2 diabetes mellitus and heart failure with preserved ejection fraction. Findings from the rica registry. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Strategy to identify subjects with diabetes mellitus more suitable for selective echocardiographic screening: The DAVID-Berg study. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Contemporary Treatment Patterns and Clinical Outcomes of Comorbid Diabetes Mellitus and HFrEF: The CHAMP-HF Registry. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Prognostic impact of diabetes mellitus in patients with heart failure and preserved ejection fraction: a prospective five-year study. [2008]