NOTIFY-HF: A Randomised Pilot Trial of Patient-Facing Early-Warning Alerts for Worsening Heart Failure Using Device-Based Multiparameter Monitoring

Aim HeartLogic (HL) is a validated multiparameter index in Boston Scientific cardiac implantable electronic devices that detects worsening heart failure (HF). However, clinician-mediated remote monitoring may delay action. Whether direct patient-facing HL alerts improve outcomes is unknown. Method Prospective, pragmatic, single-centre randomised pilot trial. Adults with HL-enabled CIEDs were allocated 1:1 to mHealth plus standard care or standard care alone. The intervention delivered weekly traffic-light notifications (Green HL <16; Amber ≥16 without symptoms; Red ≥16 with symptoms) with plain-language self-care advice. Co-primary outcomes were feasibility, usability (Mobile App Usability Questionnaire [MAUQ]), and HL recovery (alert burden and time to normalisation). Secondary outcomes included HF, and all-cause hospitalisations, 6-minute walk distance (6MWD), and N-terminal pro-B-type natriuretic peptide (NT-proBNP). Analyses were intention-to-treat. Results A total of 160 patients were enrolled (81 intervention, 79 control; mean age 65±11 years; 77% male) with median follow-up 1.82 years. Feasibility was high (80% enrolment; >85% retention), with MAUQ ≥5/7 in 78-90%. The intervention reduced HL alerts (96.5 vs 123.5 events per 100-patient-years; IRR 0.78; p=0.038) and increased non-alert days (+13%; p=0.021). Time-to-first hospitalisation favoured intervention: all-cause (HR 0.51; p=0.020), HF (HR 0.35; p=0.029). Recurrent HF hospitalisations were markedly reduced (IRR 0.17; p=0.002). The intervention improved 6MWD by 36–61 m and reduced NT-proBNP by 45%. Conclusion A patient-facing, HL-guided mHealth strategy significantly reduced alert burden and both first and recurrent hospitalizations, with clinically meaningful improvements in functional capacity and biomarkers. These findings support closing the detection–delivery gap in remote HF monitoring through direct patient engagement.