Recruiting

NT-ProBNP

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06593327

Conditions

Type 2 Diabetes

Diabetic Cardiomyopathy

Heart Failure

Cardiometabolic Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Intensive Prevention Strategy

Study Details

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

Study ID

NCT06593327

Start date

Feb 10, 2025

Status verified date

Feb, 2026

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Dec 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Primary Care Provider that sees diabetes patients in clinic

Exclusion Criteria:

  • Provider does not see patients with Diabetes

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

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

Intensive 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.

Primary outcome measure

  • Incident Heart Failure or All-cause death [ Time Frame: 2-year follow-up ]

Central Contacts and Locations

Central contacts

Ambarish Pandey, MD

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

VINAYAK SUBRAMANIAN, MD

2114-645-9868

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75209

Contacts

Ambarish Pandey, MD

214-645-9868ambarish.pandey@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Pragmatic Clinical Trial
  • Heart Failure
  • Cardiovascular Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-02-27.