NOTIFY-HF: A Randomized Pilot Trial of Patient-Facing Alerts for Worsening Heart Failure Using Multiparameter Monitoring.

BACKGROUND

Worsening heart failure is often preceded by days-to-weeks of physiological deterioration; yet, remote-monitoring alerts are clinician-facing and may not translate into timely action. The authors evaluated a patient-facing HeartLogic-guided Mobile Health (mHealth) pathway designed to augment usual care.

OBJECTIVES

The purpose of this study was to assess feasibility, acceptability, and exploratory clinical associations of a patient-facing HeartLogic-triggered early-warning pathway.

METHODS

This single-center, pragmatic, randomized pilot trial recruited adults with heart failure and a HeartLogic-capable implantable cardioverter-defibrillator, randomized 1:1 to usual care or usual care plus weekly patient-facing HeartLogic-triggered notifications via an mHealth platform with symptom screening and self-care guidance. Coprimary outcomes were feasibility/acceptability and HeartLogic recovery metrics. Follow-up ranged from 12 to 24 months.

RESULTS

A total of 160 participants were randomized (81 intervention, 79 control); median follow-up was 1.82 years. Recruitment reached 160 of 200 participants (80% of target), retention was high, and mean Mobile App Usability Questionnaire scores demonstrated acceptability throughout follow-up. Engagement was high with 80% symptom-screen completion during alerts. Compared with usual care, the intervention was associated with lower HeartLogic alert incidence (IRR: 0.78 [95% CI: 0.62-0.99]) and 13% more monitored days outside alert state (RR: 1.13 [95% CI: 1.02-1.25]), whereas time to alert normalization was similar. The traffic-light pathway supported risk-tiered patient response, with greater self-reported health care contact following red than amber alerts. Exploratory clinical outcomes were directionally favorable, but the study was not powered for these endpoints.

CONCLUSIONS

In this randomized pilot trial, a patient-facing HeartLogic-guided mHealth pathway was feasible, acceptable, and associated with lower alert burden, supporting evaluation in a larger multicenter trial.