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NCT Number: NCT05858320

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Emory University, Grady Hospital, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

SmartHF application

Other

Adaptive medication recommendations that can be shared with the participants HF provider.

Primary outcomes

  1. Primary Endpoint: Change in GDMT medication score

    Time frame: Baseline to Week 12

    Change in GDMT medication score generated by the computable algorithm from baseline to Week 12

Secondary outcomes

  1. Secondary Endpoint: Level of agreement between the medication optimization algorithm recommendations and actual GDMT prescribed

    Time frame: Over 12 Weeks

    The level of agreement between the medication optimization algorithm recommendations (Yes/No) and actual GDMT prescribed (Yes/No)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Emory University, Grady Hospital, Atlanta, GA
  • Henry Ford Hospital, Detroit, MI
  • Washington University, Barns Jewish Hospital, St. Louis, MO

Registry information

Official study title

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

Acronym: SmartHF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 15, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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