Early results from a pilot RCT of a HeartLogic-driven mHealth pathway (NOTIFY-HF) for early heart failure intervention

Background Heart failure (HF) decompensation begins weeks before symptom onset yet clinical intervention remains largely reactive. HeartLogic (HL), a multiparameter algorithm utilising physiological sensors embedded in Boston Scientific cardiac implantable electronic devices (CIEDs) predict HF deterioration with a 34-day median lead time, but current workflows prioritise clinician received alerts over patient engagement. This trial integrates HL with a mobile health (mHealth) solution, providing weekly HL feedback and patient-directed alerts enhance patient self-management. Purpose To assess the feasibility and usability of an HL-driven mHealth intervention and its impact on functional capacity, quality of life (QOL), medication adherence and early self-care. Methods HF patients with HL-enabled CIEDs were randomised to mHealth or control arms. mHealth patients received HL-triggered traffic-light notifications and symptom questionnaire(if HL ≥ 16): Green (HL < 16), Amber (HL ≥ 16; asymptomatic), Red (HL ≥ 16; symptomatic). Red alert were advised to seek clinical review; asymptomatic patients encouraged symptom vigilance. Control arm received standard CIED monitoring . Outcomes assessed at 6 months: usability and feasibility by mHealth Usability Questionnaire (MAUQ), functional capacity by 6 minute walk test (6MWT), QOL by Kansas City Cardiomyopathy Questionnaire-12 (KCCQ12), Medication adherence by 8-item Morisky Medication Adherence Scale,(MMAS-8), log-transformed NT-proBNP levels and HL trends. Results 160 HF patients were randomised (Table 1). mHealth intervention usability was maintained over 6 months, with no significant MAUQ change (p=0.79) confirming feasibility and usability across all age groups. HL alerts were more frequent in controls (64 vs 47 p>0.05) and lasted longer (p < 0.001). In 41 patients, 67 symptom screenings were completed (36 Amber alert, 31 Red alert). 20 Red Alerts sought medical review and 22 adjusted medications. Median alert duration was 9 vs 14 days (p=0.08), suggesting faster resolution in mHealth arm. The mHealth arm had significantly improved 6MWT distance (+27m vs -6m, p=0.01), trend towards lower NT-proBNP (p=0.06) and overall median HL scores (p=0.07); there were no differences in KCCQ-12. Medication adherence (MMAS-8) trended toward improvement in mHealth arm (p=0.07). Conclusion This mHealth pathway is feasible, usable and enables early clinical responses. There was improved functional capacity at 6 months. Trends suggest improved patient engagement with better medication adherence and HF stability with lower NT-proBNP and median HL scores. This support a scalable, patient-driven HL guided workflow for HF remote monitoring and self-management. Further follow up will provide greater insight into its sustained impact on patient outcomes.Table 1 - Baseline Characteristics 6MWT at Baseline vs. 6 Months