The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients

Completed · Phase 3

Conditions studied: Heart Failure

In brief

The SmartHF study is a 12-week prospective randomized controlled multicenter clinical trial. This study will investigate the efficacy of an adaptive web application to facilitate guideline-directed medical therapy (GDMT) optimization in HFrEF patients. Eligible participants will be randomized to the web application intervention or control in a 1:1 manner, stratified by site. The intervention is an adaptive medication optimization web application that extracts and analyzes the EHR data with a computable medication optimization algorithm. The algorithm provides a medication quality score and outputs medication optimization recommendations written in a patient -friendly manner.

Key facts

Study ID

NCT05858320

Run by

University of Michigan

People needed

225

Starts

2023-07-21

Expected to finish

2025-12-01

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years and older at screening
• Diagnosis of heart failure with a left ventricular ejection fraction (LVEF) </= 40% (HFrEF)
• Have a general medicine provider or general cardiology provider for HFrEF
• Have internet access and access to their health system's patient portal
• Fluent in spoken and written English
• At least two of the following: systolic blood pressure ≥ 110mmg, potassium ≤ 5.5, serum creatinine ≤ 2.5, heart rate ≥ 70
• At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or below 50% of the target dose

You may not qualify if…

• End-stage HF (hospice candidate)
• Actively treated cancer, except non-melanoma skin cancer
• Implanted ventricular assist device
• Current treatment with chronic inotropic therapy
• Patient's provider for HFrEF care is considered an advanced HF specialist
• Currently pregnant or intends to become pregnant during the study period
• Dialysis

Where it is running

• Emory University, Grady Hospital — Atlanta, Georgia, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital and Health System — Detroit, Michigan, United States
• Trinity Healthcare St. Joseph Mercy Ann Arbor — Ypsilanti, Michigan, United States
• Washington University, Barns Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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