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

NCT06593327 | Recruiting

• 1 other identifier: STU-2024-0458
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pragmatic Clinical Trial; Heart Failure; Cardiovascular Prevention

Outcome Measures

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.

  2-year follow-up

Secondary Outcomes (3)

• Prescription Rates of SGLT2i

  6-months from electronic health record alert.

• Prescription Rate of Finerenone

  6-months from electronic health record alert.

• Prescription Rate of GLP1

  6-months from electronic health record alert.

Study Arms (2)

Risk Assessment and Intensive Prevention Strategy

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Primary care providers randomized to the Usual care arm will not receive any notifications about patients with diabetes and their HF risk assessment.

Interventions

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.

Risk Assessment and Intensive Prevention Strategy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary Care Provider that sees diabetes patients in clinic

You may not qualify if:

• Provider does not see patients with Diabetes

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75209, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Cardiomyopathies; Heart Failure

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Diabetes Complications

Central Study Contacts

Ambarish Pandey, MD

CONTACT

617-869-8957; ambarish.pandey@utsouthwestern.edu

VINAYAK SUBRAMANIAN, MD

CONTACT

2114-645-9868

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: February 10, 2025
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)