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Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure

RECRUITINGN/ASponsored by University of Michigan
Actively Recruiting
PhaseN/A
SponsorUniversity of Michigan
Started2025-02-18
Est. completion2025-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

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. 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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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)

Conditions2

Heart DiseaseHeart Failure

Locations3 sites

California

1 site
Stanford Cardiovascular Clinic
Stanford, California, 94305
Kylie Oakes650-736-9831engage-hf-trial@stanford.edu

Maryland

1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Henry Zhao443-605-8435hzhao34@jhu.edu

Michigan

1 site
U-M Frankel Cardiovascular Center
Ann Arbor, Michigan, 48109
Brad Trumpower, MS734-995-0294ENGAGE-HF@med.umich.edu

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