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

Heart Failure Clinical Trial

— SmartHF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858320
• Other study ID #: HUM00227631
• Status: Recruiting
• Phase: Phase 3
• Start date: July 21, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Mike Dorsch, PharmD, MS
• Phone: 734-647-1452
• Email: mdorsch[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• SmartHF application
Adaptive medication recommendations that can be shared with the participants HF provider.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University, Grady Hospital	Atlanta	Georgia
United States	Henry Ford Hospital and Health System	Detroit	Michigan
United States	Washington University, Barns Jewish Hospital	Saint Louis	Missouri
United States	Trinity Healthcare St. Joseph Mercy Ann Arbor	Ypsilanti	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Emory University, Grady Hospital, Atlanta, GA, Henry Ford Hospital, Detroit, MI, Washington University, Barns Jewish Hospital, St. Louis, MO

Country where clinical trial is conducted

United States, 

References & 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: Advances. Published online April 12, 2023:100289.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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