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

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT06750549

Run by

University of Michigan

People needed

134

Starts

2025-02-18

Expected to finish

2026-05-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Stanford Cardiovascular Clinic — Stanford, California, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• U-M Frankel Cardiovascular Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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