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

NCT05858320 | Completed Phase 3 DMC

• 1 other identifier: HUM00227631
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Over 12 Weeks

Study Arms (2)

SmartHF application

EXPERIMENTAL

The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider.

Other: SmartHF application

Control - Patients Standard Medication(s)

ACTIVE COMPARATOR

No change to current medication(s)

Other: SmartHF application

Interventions

SmartHF application OTHER

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

Control - Patients Standard Medication(s); SmartHF application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

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

Study Sites (5)

Emory University, Grady Hospital

Atlanta, Georgia, 30303, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital and Health System

Detroit, Michigan, 48202, United States

Location

Trinity Healthcare St. Joseph Mercy Ann Arbor

Ypsilanti, Michigan, 48197, United States

Location

Washington University, Barns Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 38939592 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pharmacy, College of Pharmacy and Clinical Pharmacist, University of Michigan Inpatient Pharmacy Services

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 15, 2023
• Study Start: July 21, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (5)