NT-ProBNP-based Heart Failure Screening and Prevention Trial in Patients With Type 2 Diabetes: STRONG-DM Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensive Prevention Strategy.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Diabetic Cardiomyopathy, Heart Failure, Cardiometabolic Diseases. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
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.
Interventions
- Behavioral 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 measures
- Incident Heart Failure or All-cause death [Time frame: 2-year follow-up]
Secondary outcome measures (3)
- Prescription Rates of SGLT2i [Time frame: 6-months from electronic health record alert.]
- Prescription Rate of Finerenone [Time frame: 6-months from electronic health record alert.]
- Prescription Rate of GLP1 [Time frame: 6-months from electronic health record alert.]
Eligibility criteria
Inclusion criteria
- Primary Care Provider that sees diabetes patients in clinic
Exclusion criteria
- Provider does not see patients with Diabetes
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT06593327 · STU-2024-0458