Heart FailureENGAGE-HFNCT06750549
Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure
A study testing ENGAGE-HF Mobile Application in people with Heart Failure, run by University of Michigan at 3 sites in United States.
Trial summary
The ENGAGE-HF mobile application tracks three key features over time: (1) heart failure health status, (2) vital signs (e.g., blood pressure, heart rate) and weight, and (3) the quality of heart failure medication therapy. 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?
- ENGAGE-HF Mobile Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Feb 2025to 1 May 2026
- Phase
- Interventional
- 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
- Diagnosis of heart failure
- Last left ventricular ejection fraction within 2 years < 50% based on echocardiogram, MRI, CT, or nuclear perfusion and, if no ejection fraction documented, then clinical documentation of heart failure with reduced ejection fraction
- Currently admitted with upcoming discharge or discharged from hospital within the prior 4 weeks
- At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or at < 50% of target dose at time of enrollment
Who cannot join
- Receives dialysis
- Inotropic therapy after hospitalization
- History of a prior solid organ transplant or actively listed on heart transplant waiting list
- History of left ventricular assist device implantation
- Cardiac amyloidosis
- Currently pregnant or intends to become pregnant during the study period
Show all 14Show fewer
- Life expectancy estimated less than 6 months related to cardiac or non-cardiac comorbidities as per investigator's judgment
- Actively enrolled in hospice or comfort care
- Currently participating in an investigational device or drug study or having participated in such a study 30 days prior to screening
- Subject without a compatible smartphone
- Subject not proficient with written and spoken English
- Any other disorder or condition that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Participant has diminished decision-making capacity
- Admitted to or planned discharge to a skilled nursing facility or rehabilitation facility (acute or subacute)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
U-M Frankel Cardiovascular Center
Ann Arbor, Michigan, 48109
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Stanford Cardiovascular Clinic
Stanford, California, 94305
About this study
Official title: Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure: The ENGAGE-HF Study
The ENGAGE-HF mobile application tracks three key features over time: (1) heart failure health status, (2) vital signs (e.g., blood pressure, heart rate) and weight, and (3) the quality of heart failure medication therapy. Helping patients understand how these characteristics interact and change over time may improve their ability to understand and manage heart failure.
In this study, the investigators aim to evaluate whether the ENGAGE-HF mobile application, by facilitating the behavior change strategies of self-monitoring and feedback, and a clinician-facing dashboard, improves the optimization of heart failure guideline-directed medical therapies (GDMT) and quality of life.
An optional sub-study of cognitive function will invite all eligible participants enrolled in the main study to participate.
- Conditions
- Heart Failure
- Being tested
- ENGAGE-HF Mobile Application
- Keywords
- Medication Optimization
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENGAGE-HF Mobile ApplicationDevice
The mobile app aids ambulatory heart failure monitoring and patient engagement through several features:
Physiologic Monitoring: Daily tracking of blood pressure, weight, and heart rate using Bluetooth devices. Data is shown in graphical and tabular formats.
Health Status Assessment: Biweekly KCCQ-12 surveys and dizziness questions provide scores (0-100), helping visualize therapy benefits and medication adherence, and reducing clinician inertia.
Medication Checklist: Lists current medications and target doses for common heart failure therapies, encouraging adherence and optimization, with alerts for potential improvements.
Education: Animated videos from heart failure experts and societies explain medications, monitoring rationale, app features, and interpretation of data.
The app enhances heart failure management via consistent monitoring, assessment, medication adherence, and educational content.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The ENGAGE-HF intervention is a combination of a patient-facing mobile application that is integrated with a remote blood pressure cuff and scale along with a clinician-facing dashboard. The mobile application helps complete standard ambulatory monitoring recommended by heart failure clinicians. Simultaneously, the application includes visualizations of that data and education for patients that is intended to promote patient engagement and patient understanding of heart failure care. The information is then made available to treating clinicians via a PDF summary to facilitate outpatient management of the patient by the clinician. There are also a select set of notifications triggered by the ENGAGE-HF platform that will be transmitted to the treating clinician. Receives: Device: ENGAGE-HF Mobile Application |
| Control Group | No intervention | Participants randomized to the control group will receive usual heart failure care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication optimization score at 90 days
The primary outcome will be the difference in the medication optimization score at 90 days between the intervention and control group. The MOS is a percent between 0 (least optimized) and 100 (most optimized), which represents the extent of medication optimization that needs to be performed. Inputs for the score include medications, vital signs, and laboratory values, and thus, the score accounts for contraindications to medical therapy titration. The score has been shown to correlate with clinical outcomes in two large randomized controlled trials.
Measured: From enrollment to the end of participation at 90 days
Secondary outcomes (1)
Kansas City Cardiomyopathy Questionnaire (KCCQ-23)
The secondary outcome will be heart failure symptoms as assessed by the difference between the intervention and the control groups in the 23-item Kansas City Cardiomyopathy Questionnaires (KCCQ-23) clinical summary score at 90 days.
The KCCQ-23 quantifies patients' health status over the prior 2 weeks and has extensive data supporting its validity, reliability, and sensitivity to clinical change. Scores will be transformed into a 0-100 point rating, with lower scores representing worse health status.
Measured: Baseline and at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start18 Feb 2025
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization by site
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Johns Hopkins University, Boston University
- Responsible party
- Principal investigator, Michael Dorsch, University of Michigan
- Investigators
- Michael Dorsch, PharmD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750549
- Sponsor's protocol ID
- HUM00240067
- Acronym
- ENGAGE-HF
- Status last verified
- May 2026
- First submitted
- 11 Dec 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure: The ENGAGE-HF Study
- ClinicalTrials.gov ID
- NCT06750549
- Acronym / sponsor ID
- ENGAGE-HF / HUM00240067
- Conditions
- Heart Failure
- Keywords
- Medication Optimization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Stanford University, Johns Hopkins University, Boston University
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 27 Dec 2024 (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 ENGAGE-HF mobile application tracks three key features over time: (1) heart failure health status, (2) vital signs (e.g., blood pressure, heart rate) and weight, and (3) the quality of heart failure medication therapy. Helping patients understand how these characteristics interact and change over time may improve their ability to understand and manage heart failure.
In this study, the investigators aim to evaluate whether the ENGAGE-HF mobile application, by facilitating the behavior change strategies of self-monitoring and feedback, and a clinician-facing dashboard, improves the optimization of heart failure guideline-directed medical therapies (GDMT) and quality of life.
An optional sub-study of cognitive function will invite all eligible participants enrolled in the main study to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization by site
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: ENGAGE-HF Mobile ApplicationThe ENGAGE-HF intervention is a combination of a patient-facing mobile application that is integrated with a remote blood pressure cuff and scale along with a clinician-facing dashboard. The mobile application helps complete standard ambulatory monitoring recommended by heart failure clinicians. Simultaneously, the application includes visualizations of that data and education for patients that is intended to promote patient engagement and patient understanding of heart failure care. The information is then made available to treating clinicians via a PDF summary to facilitate outpatient management of the patient by the clinician. There are also a select set of notifications triggered by the ENGAGE-HF platform that will be transmitted to the treating clinician. |
| Control Group | No intervention | –Participants randomized to the control group will receive usual heart failure care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of heart failure
- Last left ventricular ejection fraction within 2 years < 50% based on echocardiogram, MRI, CT, or nuclear perfusion and, if no ejection fraction documented, then clinical documentation of heart failure with reduced ejection fraction
- Currently admitted with upcoming discharge or discharged from hospital within the prior 4 weeks
- At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or at < 50% of target dose at time of enrollment
Key exclusion criteria (14 listed)
- Receives dialysis
- Inotropic therapy after hospitalization
- History of a prior solid organ transplant or actively listed on heart transplant waiting list
- History of left ventricular assist device implantation
- Cardiac amyloidosis
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 |
|---|---|---|
| ENGAGE-HF Mobile ApplicationThe mobile app aids ambulatory heart failure monitoring and patient engagement through several features: Physiologic Monitoring: Daily tracking of blood pressure, weight, and heart rate using Bluetooth devices. Data is shown in graphical and tabular formats. Health Status Assessment: Biweekly KCCQ-12 surveys and dizziness questions provide scores (0-100), helping visualize therapy benefits and medication adherence, and reducing clinician inertia. Medication Checklist: Lists current medications and target doses for common heart failure therapies, encouraging adherence and optimization, with alerts for potential improvements. Education: Animated videos from heart failure experts and societies explain medications, monitoring rationale, app features, and interpretation of data. The app enhances heart failure management via consistent monitoring, assessment, medication adherence, and educational content. | Device | Intervention |
Primary outcome
Medication optimization score at 90 days
Time frame: From enrollment to the end of participation at 90 days
The primary outcome will be the difference in the medication optimization score at 90 days between the intervention and control group. The MOS is a percent between 0 (least optimized) and 100 (most optimized), which represents the extent of medication optimization that needs to be performed. Inputs for the score include medications, vital signs, and laboratory values, and thus, the score accounts for contraindications to medical therapy titration. The score has been shown to correlate with clinical outcomes in two large randomized controlled trials.
1 secondary outcome
Kansas City Cardiomyopathy Questionnaire (KCCQ-23)
Time frame: Baseline and at 90 days
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 22 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Michael Dorsch, PharmD principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENGAGE-HF Mobile Application in people with Heart Failure, run by University of Michigan at 3 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 4 inclusion and 14 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Medication optimization score at 90 days (time frame: From enrollment to the end of participation at 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.