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

NCT ID: NCT06593327

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2027-12-15

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Diabetic Cardiomyopathy Heart Failure Cardiometabolic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intensive Prevention Strategy

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Primary Care Provider that sees diabetes patients in clinic

Exclusion Criteria

* Provider does not see patients with Diabetes
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Diagnostics GmbH

INDUSTRY

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ambarish Pandey

Associate Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ambarish Pandey, MD

Role: CONTACT

617-869-8957

VINAYAK SUBRAMANIAN, MD

Role: CONTACT

2114-645-9868

Facility Contacts

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Ambarish Pandey, MD

Role: primary

214-645-9868

Other Identifiers

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STU-2024-0458

Identifier Type: -

Identifier Source: org_study_id

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