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RecruitingNCT06593327STRONG-DMUpdated Sep 29, 2026

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

An interventional study of Intensive Prevention Strategy in Type 2 Diabetes, Diabetic Cardiomyopathy and Heart Failure, sponsored by University of Texas Southwestern Medical Center. Recruiting at 3 sites in United States. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes
  • Diabetic Cardiomyopathy
  • Heart Failure
  • Cardiometabolic Diseases

Keywords

  • Pragmatic Clinical Trial
  • Heart Failure
  • Cardiovascular Prevention
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Primary Care Provider that sees diabetes patients in clinic

Exclusion criteria

Exclusion Criteria:

  • Provider does not see patients with Diabetes
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • 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.

    Behavioral: Intensive Prevention Strategy

  • 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.

Interventions

  • BehavioralIntensive Prevention Strategy

    Providers randomized to the intensive prevention strategy will receive notification about patients with diabetes who have high heart failure risk and recommendations for medical management, e-consultation, or referral to a cardiometabolic risk management program.

05

What researchers measure

Primary outcomes

  1. Incident Heart Failure or All-cause death

    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.

    Time frame: 2-year follow-up

Secondary outcomes

  1. Prescription Rates of SGLT2i

    Counts of SGLT2 inhibitor prescriptions filled

    Time frame: 6-months from electronic health record alert.

  2. Prescription Rate of Finerenone

    Counts of Finerenone prescriptions

    Time frame: 6-months from electronic health record alert.

  3. Prescription Rate of GLP1

    Counts of GLP1 prescription

    Time frame: 6-months from electronic health record alert.

06

Study locations

3 of 3 sites recruiting
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75209, United States
    Recruiting
  • Parkland Health & Hospital System (PHHS)
    Dallas, Texas 75235, United States
    Recruiting
  • Baylor Scott and White - Health System
    Dallas, Texas 75246, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06593327
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
Roche Diagnostics GmbH
Responsible party
Ambarish Pandey (Associate Professor of Internal Medicine, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Sep 19, 2024
Start date
Feb 10, 2025
Primary completion
Dec 10, 2027 (estimated)
Completion
Dec 15, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Ambarish Pandey, MD
Contact
ambarish.pandey@utsouthwestern.edu
617-869-8957
VINAYAK SUBRAMANIAN, MD
Contact
2114-645-9868

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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