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
Trial tests new way to screen and prevent heart failure in people with type 2 diabetes.
Plain English Summary
NT-ProBNP-based Heart Failure Screening and Prevention Trial in Patients With Type 2 Diabetes: STRONG-DM Study is a Not Applicable clinical trial sponsored by University of Texas Southwestern Medical Center studying Type 2 Diabetes, Diabetic Cardiomyopathy, Heart Failure, Cardiometabolic Diseases. This study tests a new strategy to identify and prevent heart failure in individuals with type 2 diabetes. It is for adults with type 2 diabetes who are at high risk for heart failure. Participants will be randomly assigned to either the new screening strategy or standard care. The alternative is to continue with current standard medical care for diabetes and heart health. The trial aims to enroll 300 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with type 2 diabetes who are seen by a primary care provider. Individuals must have a primary care provider who manages their diabetes. There are no specific age or health requirements listed beyond having type 2 diabetes. This trial is studying Type 2 Diabetes, Diabetic Cardiomyopathy, Heart Failure, Cardiometabolic Diseases, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if this new screening approach reduces the number of people who develop heart failure or die from any cause over two years. The specific primary outcome measures are: Incident Heart Failure or All-cause death (2-year follow-up). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to fill a gap in preventing heart failure, a serious complication, in the large population of people with type 2 diabetes. This research targets Type 2 Diabetes, Diabetic Cardiomyopathy, Heart Failure, Cardiometabolic Diseases, where improved treatment options are needed.
Investor Insight
This trial addresses a significant unmet need in managing cardiometabolic risk in diabetes patients, a large and growing market, with potential to improve guideline adherence for preventive therapies.
Is This Trial Right for Me?
Ask your doctor if you have type 2 diabetes and are at high risk for heart failure. Participation involves being randomly assigned to a new screening and prevention plan or continuing with your regular care. The new plan may involve more frequent check-ins or specific medication recommendations based on risk assessment. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 300 participants
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 Outcomes
- Incident Heart Failure or All-cause death (2-year follow-up)
Secondary Outcomes
- 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.)
Full Eligibility Criteria
Inclusion Criteria: * Primary Care Provider that sees diabetes patients in clinic Exclusion Criteria: * Provider does not see patients with Diabetes
Trial Locations
- University of Texas Southwestern Medical Center, Dallas, Texas, United States
Frequently Asked Questions
What is clinical trial NCT06593327?
NCT06593327 is a Not Applicable INTERVENTIONAL study titled "NT-ProBNP-based Heart Failure Screening and Prevention Trial in Patients With Type 2 Diabetes: STRONG-DM Study." It is currently recruiting and is sponsored by University of Texas Southwestern Medical Center. The trial targets enrollment of 300 participants.
What conditions does NCT06593327 study?
This trial investigates treatments for Type 2 Diabetes, Diabetic Cardiomyopathy, Heart Failure, Cardiometabolic Diseases. The primary condition under study is Type 2 Diabetes.
What treatments are being tested in NCT06593327?
The interventions being studied include: 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.
What does Not Applicable mean for NCT06593327?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06593327?
This trial is currently "Recruiting." It started on 2025-02-10. The estimated completion date is 2027-12-15.
Who is sponsoring NCT06593327?
NCT06593327 is sponsored by University of Texas Southwestern Medical Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06593327?
The trial aims to enroll 300 participants. The trial is currently recruiting and accepting new participants.
How is NCT06593327 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06593327?
The primary outcome measures are: Incident Heart Failure or All-cause death (2-year follow-up). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06593327 being conducted?
This trial is being conducted at 1 site, including Dallas, Texas (United States).
Where can I find official information about NCT06593327?
The official record for NCT06593327 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06593327. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06593327 testing in simple terms?
This study tests a new strategy to identify and prevent heart failure in individuals with type 2 diabetes. It is for adults with type 2 diabetes who are at high risk for heart failure.
Why is this trial significant?
This trial matters because it aims to fill a gap in preventing heart failure, a serious complication, in the large population of people with type 2 diabetes.
What are the potential risks of participating in NCT06593327?
Potential risks include anxiety or stress from being identified as high-risk for heart failure. Side effects would be related to any new medications or treatments recommended as part of the intensive prevention strategy, not the screening itself. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06593327?
Ask your doctor if you have type 2 diabetes and are at high risk for heart failure. Participation involves being randomly assigned to a new screening and prevention plan or continuing with your regular care. The new plan may involve more frequent check-ins or specific medication recommendations based on risk assessment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06593327 signal from an investment perspective?
This trial addresses a significant unmet need in managing cardiometabolic risk in diabetes patients, a large and growing market, with potential to improve guideline adherence for preventive therapies. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to either the new screening strategy or standard care. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.