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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes; Diabetic Cardiomyopathy; Heart Failure; Cardiometabolic Diseases
• Interventions: Behavioral: Intensive Prevention Strategy

• Registration Number: NCT06593327
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Status Verified: 2025-02
• Study Start: 2025-02-10
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-27
• Primary Completion: 2027-12-10
• Study Completion: 2027-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Primary Care Provider that sees diabetes patients in clinic

Exclusion Criteria

• Provider does not see patients with Diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risk Assessment and Intensive Prevention Strategy	Intensive Prevention Strategy	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.

Primary Outcome Measures

Name	Time	Method
Incident Heart Failure or All-cause death	2-year follow-up	Incident Heart Failure (based on electronic health record International Classification of Diseases codes) or all-cause death. This will be assessed via retrospective chart review.

Secondary Outcome Measures

Name	Time	Method
Prescription Rates of SGLT2i	6-months from electronic health record alert.	Counts of SGLT2 inhibitor prescriptions filled
Prescription Rate of Finerenone	6-months from electronic health record alert.	Counts of Finerenone prescriptions
Prescription Rate of GLP1	6-months from electronic health record alert.	Counts of GLP1 prescription

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States