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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Primary Care Provider that sees diabetes patients in clinic

Disqualifiers

Provider does not see patients with Diabetes

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Risk Assessment and Intensive Prevention StrategyExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.