Actively Recruiting
Evaluation of a Pragmatic NT-ProBNP-based Heart Failure Screening Strategy Among Patients With Type 2 Diabetes: STRONG-DM Study
Led by University of Texas Southwestern Medical Center · Updated on 2026-02-27
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
R
Roche Diagnostics GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a heart failure risk assessment and prevention strategy for patients with type 2 diabetes. This trial evaluates a clinical decision support tool that uses heart failure risk scores (WATCH-DM) and a cardiac biomarker (NT-proBNP) to guide providers in implementing intensive prevention strategies. The aim is to improve the use of evidence-based therapies to prevent heart failure in high-risk patients with diabetes. Primary care providers are randomly assigned to either an intervention group that receives notifications through the electronic health record about patients at high risk for heart failure or a usual care group that does not receive such notifications. Providers in the intervention group get recommendations to start therapies like SGLT2 inhibitors, GLP1 agonists, or non-steroidal MRAs, with options for expert e-consultation or referral to a cardiometabolic risk management program. Participants' involvement includes routine clinical care with electronic health record monitoring over a two-year follow-up to track incident heart failure or all-cause death. Researchers will measure prescription rates of the recommended therapies within six months of alert notifications. The study focuses on how well the risk assessment and prevention strategy can be integrated into primary care to improve outcomes for patients with type 2 diabetes.
CONDITIONS
Brief Title
NT-ProBNP-based Heart Failure Screening and Prevention Trial in Patients With Type 2 Diabetes: STRONG-DM Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary Care Provider that sees diabetes patients in clinic
You will not qualify if you...
- Provider does not see patients with Diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive care under their primary care providers who use an intensive prevention strategy based on heart failure risk notifications and recommendations.
Ongoing visits as part of routine primary care
Duration - 2 years
Participants are followed to observe incident heart failure or all-cause death and prescription rates after notification alerts.
Follow-up through electronic health records with prescription monitoring at 6 months
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75209
Actively Recruiting
Research Team
A
Ambarish Pandey, MD
V
VINAYAK SUBRAMANIAN, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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