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

NCT ID: NCT05858320

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-21
• Study Completion Date: 2025-12-01

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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SmartHF application

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

Group Type: EXPERIMENTAL

SmartHF application

Intervention Type: OTHER

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

Control - Patients Standard Medication(s)

No change to current medication(s)

Group Type: ACTIVE_COMPARATOR

SmartHF application

Intervention Type: OTHER

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

Interventions

SmartHF application

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University, Barns Jewish Hospital, St. Louis, MO

UNKNOWN

Sponsor Role: collaborator

Henry Ford Hospital, Detroit, MI

UNKNOWN

Sponsor Role: collaborator

Emory University, Grady Hospital, Atlanta, GA

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Michael Dorsch

Associate Professor of Pharmacy, College of Pharmacy and Clinical Pharmacist, University of Michigan Inpatient Pharmacy Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 38939592 (View on PubMed)

Other Identifiers

HUM00227631

Identifier Type: -

Identifier Source: org_study_id