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Behavioral Intervention

Prevention Strategy for Heart Failure in Type 2 Diabetes (STRONG-DM Trial)

N/A
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-year follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a strategy to assess and prevent heart failure in high-risk patients. It involves using risk scores and a cardiac biomarker along with a support tool to guide intensive prevention efforts.

Who is the study for?
This trial is for people with Type 2 Diabetes who are at risk of developing heart failure. Participants should not have a current diagnosis of heart failure but must be considered high-risk based on specific clinical scores and biomarkers.
What is being tested?
The study tests whether using a special prevention strategy that includes regular health checks, risk assessments, and treatments can help prevent heart failure in high-risk diabetes patients.
What are the potential side effects?
Since the intervention involves an intensive prevention strategy rather than a specific medication, side effects may vary widely depending on the individual treatments used within the strategy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incident Heart Failure or All-cause death
Secondary study objectives
Prescription Rate of Finerenone
Prescription Rate of GLP1
Prescription Rates of SGLT2i

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Risk Assessment and Intensive Prevention StrategyExperimental Treatment1 Intervention
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 II: Usual CareActive Control1 Intervention
Primary care providers randomized to the Usual care arm will not receive any notifications about patients with diabetes and their HF risk assessment.

Find a Location

Who is running the clinical trial?

Roche Diagnostics GmbHIndustry Sponsor
62 Previous Clinical Trials
655,676 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,077 Previous Clinical Trials
1,055,761 Total Patients Enrolled
~200 spots leftby Dec 2026
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