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Behavioural Intervention

SmartHF Application for Heart Failure (SmartHF Trial)

Phase 3
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or below 50% of the target dose
Age 18 years and older at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 12 weeks
Awards & highlights

SmartHF Trial Summary

This trial will investigate if a web application can help optimize medication for people with heart failure.

Who is the study for?
This trial is for adults over 18 with heart failure (HFrEF) and a left ventricular ejection fraction of 40% or less. They should be on less than half the target dose of certain heart medications, have internet access, speak English, and not be under advanced HF specialist care. Excluded are those in end-stage HF, on dialysis, with active cancer (except skin), pregnant women, those with implanted heart devices or on chronic inotropic drugs.Check my eligibility
What is being tested?
The SmartHF study tests an adaptive web app designed to help HFrEF patients manage their medication better using their electronic health records. Over 12 weeks at multiple centers, participants will either use this SmartHF application or receive standard care without it; they're randomly assigned to one of these two groups equally.See study design
What are the potential side effects?
Since the intervention is a web application aimed at optimizing medication use rather than a drug itself, there are no direct side effects like you'd expect from medication. However, users may experience issues related to technology use such as privacy concerns or stress due to misinterpretation of information.

SmartHF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not on full doses of at least two recommended heart failure medications.
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I am 18 years old or older.
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My heart's pumping ability is reduced (LVEF ≤ 40%).

SmartHF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint: Change in GDMT medication score
Secondary outcome measures
Secondary Endpoint: Level of agreement between the medication optimization algorithm recommendations and actual GDMT prescribed

SmartHF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SmartHF applicationExperimental Treatment1 Intervention
The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider.
Group II: Control - Patients Standard Medication(s)Active Control1 Intervention
No change to current medication(s)

Find a Location

Who is running the clinical trial?

Henry Ford Hospital, Detroit, MIUNKNOWN
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,377,913 Total Patients Enrolled
25 Trials studying Heart Failure
11,891 Patients Enrolled for Heart Failure
Emory University, Grady Hospital, Atlanta, GAUNKNOWN

Media Library

SmartHF application (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05858320 — Phase 3
Heart Failure Research Study Groups: Control - Patients Standard Medication(s), SmartHF application
Heart Failure Clinical Trial 2023: SmartHF application Highlights & Side Effects. Trial Name: NCT05858320 — Phase 3
SmartHF application (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05858320 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals currently access this clinical experiment?

"The clinicaltrial.gov page for this trial reveals that it is not actively recruiting patients, as the last update was on May 10th 2023. However, there are currently 729 other trials which require participants at this particular moment in time."

Answered by AI

How hazardous is the SmartHF program to clinical users?

"Our team has assigned SmartHF application a score of 3, indicating that there is ample evidence to suggest it's efficacy and safety from prior clinical trials."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Emory University, Grady Hospital
Washington University, Barns Jewish Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~150 spots leftby Jun 2026