Heart FailurePhase 3SmartHFNCT05858320
The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients
A Phase 3 study testing SmartHF application in people with Heart Failure, run by University of Michigan at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- SmartHF application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Jul 2023to 1 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University, Grady Hospital
Atlanta, Georgia, 30303
Henry Ford Hospital and Health System
Detroit, Michigan, 48202
Washington University, Barns Jewish Hospital
St Louis, Missouri, 63110
Trinity Healthcare St. Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197
About this study
Official title: 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.
Read the 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
- Being tested
- SmartHF application
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartHF applicationOther
Adaptive medication recommendations that can be shared with the participants HF provider.
| Study group | Role | What they receive |
|---|---|---|
| SmartHF application | Experimental | The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider. Receives: Other: SmartHF application |
| Control - Patients Standard Medication(s) | Active comparator | No change to current medication(s) Receives: Other: SmartHF application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint: Change in GDMT medication score
Change in GDMT medication score generated by the computable algorithm from baseline to Week 12
Measured: Baseline to Week 12
Secondary outcomes (1)
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)
Measured: Over 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start21 Jul 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University, Barns Jewish Hospital, St. Louis, MO, Henry Ford Hospital, Detroit, MI, Emory University, Grady Hospital, Atlanta, GA
- Responsible party
- Principal investigator, Michael Dorsch, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858320
- Sponsor's protocol ID
- HUM00227631
- Acronym
- SmartHF
- Status last verified
- Jan 2026
- First submitted
- 1 May 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 38939592Dorsch MP, Krambrink A, Ganai S, Greer KM, Ali MS, Stevens R, Nwoko U, Ogunniyi MO, Ewald G, Abdul-Nour K, Hummel SL, Koelling TM. The impact of an adaptive patient-centered web application on medication optimization in patients with HFrEF: Rationale and design of the SmartHF trial. Am Heart J Plus. 2026 Oct 6;71:100934. doi: 10.1016/j.ahjo.2026.100934. eCollection 2026 Nov.
PubMed 42898174
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients (SmartHF)
- ClinicalTrials.gov ID
- NCT05858320
- Acronym / sponsor ID
- SmartHF / HUM00227631
- Conditions
- Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Washington University, Barns Jewish Hospital, St. Louis, MO, Henry Ford Hospital, Detroit, MI, Emory University, Grady Hospital, Atlanta, GA
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SmartHF application | Experimental | Other: SmartHF applicationThe web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider. |
| Control - Patients Standard Medication(s) | Active comparator | Other: SmartHF applicationNo change to current medication(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartHF applicationAdaptive medication recommendations that can be shared with the participants HF provider. | Other | Control - Patients Standard Medication(s), SmartHF application |
Primary outcome
Primary Endpoint: Change in GDMT medication score
Time frame: Baseline to Week 12
Change in GDMT medication score generated by the computable algorithm from baseline to Week 12
1 secondary outcome
Secondary Endpoint: Level of agreement between the medication optimization algorithm recommendations and actual GDMT prescribed
Time frame: Over 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 38939592Dorsch 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.
- Derived from this study: PubMed 42898174Dorsch MP, Krambrink A, Ganai S, Greer KM, Ali MS, Stevens R, Nwoko U, Ogunniyi MO, Ewald G, Abdul-Nour K, Hummel SL, Koelling TM. The impact of an adaptive patient-centered web application on medication optimization in patients with HFrEF: Rationale and design of the SmartHF trial. Am Heart J Plus. 2026 Oct 6;71:100934. doi: 10.1016/j.ahjo.2026.100934. eCollection 2026 Nov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SmartHF application in people with Heart Failure, run by University of Michigan at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint: Change in GDMT medication score (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05858320, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.