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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-year follow-up

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.

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