N/A Completed N=54 Health Services Research

The Cascade Feasibility Pilot (HF) Phase 3

Heart Failure

Source: ClinicalTrials.gov NCT04993287 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcomePrimary: Enrollment Rate — 39 Participants

Summary

The study proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, and heart failure specialists, and has the potential to transform heart failure management in the post-discharge period, where patients are the most vulnerable for readmission. This feasibility study will contribute to the understanding of post-discharge heart failure continuous remote patient monitoring, promote patient self-care, and has the potential of improving patient outcomes.

Outcome Measures

Outcome	Result	p-value
PRIMARY Enrollment Rate	39	—
PRIMARY Adherence Rate	27	—
SECONDARY Documented Diuretic Escalation	17	—
SECONDARY 30-day Readmission Rate	6	—

Eligibility Criteria

Inclusion Criteria

Patient is an inpatient at Evanston Hospital
Patient is followed by the heart failure service team after discharge
Patient has a history of heart failure
Patient received at least one dose of IV diuretic at index hospitalization
Symptoms corresponding to NYHA function class II-IV
Patient has heart failure with reduced left ventricular ejection fraction (LVEF)<40%, or HF with mid-ranged ejection fraction (LVEF 40-50%), or HF with preserved ejection fraction (LVEF≥50%)
Patient is in the top 50% risk of readmission across NorthShore University HealthSystem's CAPE 30-day readmission model
Patient is at least 18 years of age
Patient is fluent in English
Patient agrees to protocol-required procedures

Exclusion Criteria

Patient has cognitive or physical limitations that, in the investigator's opinion, limit the patient's ability to maintain patch device and phone
Patient has visual impairments
Patient has an allergy to hydrocolloid adhesives
Patient has present skin damage preventing them from wearing a study device
Patient has renal dysfunction requiring dialysis
Patient has CardioMEMS
Pregnancy
Patient receiving hospice care

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04993287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.