A Phase 3 interventional study of SmartHF application in Heart Failure, sponsored by University of Michigan. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by University of Michigan · Phase 3, Interventional, and Treatment
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.
The investigators have developed an adaptive medication optimization web application, named SmartHF, that provides patients with tailored information about potential HFrEF GDMT optimization. SmartHF guides patients to share the GDMT optimization recommendations with their provider during a clinic visit.
Participants will be randomized to receive the web application intervention or control up to 30 days before a clinic visit in a 1:1 manner and followed for 12 weeks after the clinic visit. This trial will determine the efficacy of SmartHF in prescribing GDMT in HFrEF patients compared to controls.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 225 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider.
Other: SmartHF application
No change to current medication(s)
Other: SmartHF application
Adaptive medication recommendations that can be shared with the participants HF provider.
Primary Endpoint: Change in GDMT medication score
Change in GDMT medication score generated by the computable algorithm from baseline to Week 12
Time frame: Baseline to Week 12
Secondary Endpoint: Level of agreement between the medication optimization algorithm recommendations and actual GDMT prescribed
The level of agreement between the medication optimization algorithm recommendations (Yes/No) and actual GDMT prescribed (Yes/No)
Time frame: Over 12 Weeks
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of Michigan