Type 2 DiabetesSTRONG-DMNCT06593327
NT-ProBNP-based Heart Failure Screening and Prevention Trial in Patients With Type 2 Diabetes: STRONG-DM Study
A study testing Intensive Prevention Strategy in people with Type 2 Diabetes and Diabetic Cardiomyopathy, run by University of Texas Southwestern Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes, Diabetic Cardiomyopathy, Heart Failure
- What is being tested?
- Intensive Prevention Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Feb 2025to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary Care Provider that sees diabetes patients in clinic
Who cannot join
- Provider does not see patients with Diabetes
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
VINAYAK SUBRAMANIAN, MD contact
United States3 sites, 3 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75209
Ambarish Pandey, MD, 214-645-9868, ambarish.pandey@utsouthwestern.edu
- Recruiting
Parkland Health & Hospital System (PHHS)
Dallas, Texas, 75235
Ambarish Pandey, MD, 888-287-1082, Ambarish.Pandey@UTSouthwestern.edu
- Recruiting
Baylor Scott and White - Health System
Dallas, Texas, 75246
Neil Keshvani, MD, 469-800-5260, neil.keshvani@bswhealth.org
About this study
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
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.
Read the 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.
- Being tested
- Intensive Prevention Strategy
- Keywords
- Pragmatic Clinical Trial, Heart Failure, Cardiovascular Prevention
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Prevention StrategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-year follow-up
Secondary outcomes (3)
Prescription Rates of SGLT2i
Counts of SGLT2 inhibitor prescriptions filled
Measured: 6-months from electronic health record alert.
Prescription Rate of Finerenone
Counts of Finerenone prescriptions
Measured: 6-months from electronic health record alert.
Prescription Rate of GLP1
Counts of GLP1 prescription
Measured: 6-months from electronic health record alert.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Feb 2025
- Primary completion10 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Principal investigator, Ambarish Pandey, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593327
- Sponsor's protocol ID
- STU-2024-0458
- Acronym
- STRONG-DM
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06593327
- Acronym / sponsor ID
- STRONG-DM / STU-2024-0458
- Keywords
- Pragmatic Clinical Trial, Heart Failure, Cardiovascular Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk Assessment and Intensive Prevention Strategy | Experimental | Behavioral: Intensive Prevention StrategyPrimary 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary Care Provider that sees diabetes patients in clinic
Key exclusion criteria (1 listed)
- Provider does not see patients with Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Prevention StrategyProviders 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. | Behavioural | Risk Assessment and Intensive Prevention Strategy |
Primary outcome
Incident Heart Failure or All-cause death
Time frame: 2-year follow-up
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
VINAYAK SUBRAMANIAN, MD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Prevention Strategy in people with Type 2 Diabetes and Diabetic Cardiomyopathy, run by University of Texas Southwestern Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ambarish Pandey, MD (617-869-8957, ambarish.pandey@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident Heart Failure or All-cause death (time frame: 2-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.