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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: SmartHF application

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University, Grady Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital and Health System
    • Ypsilanti, Michigan, United States, 48197
      • Trinity Healthcare St. Joseph Mercy Ann Arbor
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University, Barns Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years and older at screening
2. Diagnosis of heart failure with a left ventricular ejection fraction (LVEF) </= 40% (HFrEF)
3. Have a general medicine provider or general cardiology provider for HFrEF
4. Have internet access and access to their health system's patient portal
5. Fluent in spoken and written English
6. At least two of the following: systolic blood pressure ≥ 110mmg, potassium ≤ 5.5, serum creatinine ≤ 2.5, heart rate ≥ 70
7. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SmartHF application; The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider.	Other: SmartHF application; Adaptive medication recommendations that can be shared with the participants HF provider.
Active Comparator: Control - Patients Standard Medication(s); No change to current medication(s)	Other: SmartHF application; Adaptive medication recommendations that can be shared with the participants HF provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint: Change in GDMT medication score	Change in GDMT medication score generated by the computable algorithm from baseline to Week 12	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Over 12 Weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Washington University, Barns Jewish Hospital, St. Louis, MO; Henry Ford Hospital, Detroit, MI; Emory University, Grady Hospital, Atlanta, GA

Publications and helpful links

General Publications

• Dorsch MP, Sifuentes A, Cordwin DJ, Kuo R, Rowell BE, Arzac JJ, DeBacker K, Guidi JL, Hummel SL, Koelling TM. A Computable Algorithm for Medication Optimization in Heart Failure With Reduced Ejection Fraction. JACC Adv. 2023 Apr 12;2(3):100289. doi: 10.1016/j.jacadv.2023.100289. eCollection 2023 May.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: HUM00227631

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No