Evaluation of a Pragmatic NT-ProBNP-based Heart Failure Screening Strategy Among Patients with Type 2 Diabetes: STRONG-DM Study (Screening and Treatment Using Risk-based ApprOach with NT-ProBNP Guidance in Diabetes Mellitus
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Primary Care Provider that sees diabetes patients in clinic
Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Ambarish Pandey, MD
ambarish.pandey@utsouthwestern.edu
617-869-8957
Backup
VINAYAK SUBRAMANIAN, MD
2114-645-9868
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 300
Treatments
Experimental: Risk Assessment and 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.
No_intervention: Usual Care
Primary care providers randomized to the Usual care arm will not receive any notifications about patients with diabetes and their HF risk assessment.
Related Therapeutic Areas
Sponsors
Collaborators: Roche Diagnostics GmbH
Leads: University of Texas Southwestern Medical Center