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NCT Number: NCT06593327

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

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.

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Key information

Conditions

Type 2 Diabetes Cardiometabolic Diseases Cardiomyopathies Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Cardiomyopathies Diabetic Cardiomyopathy Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75209, United States

Location status: Recruiting

Location contact

Ambarish Pandey, MD

CONTACT

[email protected]

214-645-9868

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary Care Provider that sees diabetes patients in clinic

Exclusion criteria

  • Provider does not see patients with Diabetes

Treatment and study plan

Intensive Prevention Strategy

Behavioral

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.

Primary outcomes

  1. Incident Heart Failure or All-cause death

    Time frame: 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 outcomes

  1. Prescription Rates of SGLT2i

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

    Counts of SGLT2 inhibitor prescriptions filled

  2. Prescription Rate of Finerenone

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

    Counts of Finerenone prescriptions

  3. Prescription Rate of GLP1

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

    Counts of GLP1 prescription

Study contacts

Contact information is provided by the study sponsor or research team.

Ambarish Pandey, MD

CONTACT

[email protected]

617-869-8957

VINAYAK SUBRAMANIAN, MD

CONTACT

2114-645-9868

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Official study title

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

Acronym: STRONG-DM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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