NT-ProBNP-based Heart Failure Screening and Prevention Trial in Patients With Type 2 Diabetes: STRONG-DM Study

The University of Texas System (UT)

Status: Begins enrollment this month

Conditions: Diabetic Cardiomyopathy; Cardiometabolic Diseases; Heart Failure; Type 2 Diabetes

Treatments: Behavioral: Intensive Prevention Strategy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06593327

STU-2024-0458

Details and patient eligibility

About

A pragmatic, randomized clinical trial to evaluate the effect of a heart failure (HF) risk assessment and prevention strategy incorporating HF clinical risk scores (WATCH-DM) with cardiac biomarker (NT-proBNP) paired with a clinical decision support tool to implement an intensive prevention strategy among patients with high risk focused on implementation of evidence-based HF preventive therapies.

Full description

Primary care providers will be randomized to receive notifications via the electronic health record if any patients with diabetes have high heart failure risk based on a combination of clinical risk scores(WATCH-DM), and biomarkers (NT-proBNP). Providers will be provided recommendation to initiate evidence based therapies (SGLT2 inhibitors, GLP1 agonists, non-steroidal MRA) , obtain expert e-consultation, or refer the patient to a cardiometabolic risk management program.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary Care Provider that sees diabetes patients in clinic

Exclusion criteria

• Provider does not see patients with Diabetes

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Risk Assessment and Intensive Prevention Strategy

Experimental group

Description:

Primary care providers (PCP) randomized to the Risk Assessment and Intensive Prevention Strategy Arm will receive notification if any patients with diabetes under their care have high heart failure risk based on clinical or biomarker scores. Providers will receive recommendations, option for e-consultation, and referral to cardiometabolic risk management program.

Treatment:

Behavioral: Intensive Prevention Strategy

Usual Care

No Intervention group

Description:

Primary care providers randomized to the Usual care arm will not receive any notifications about patients with diabetes and their HF risk assessment.