Risk-Based Nurse-Managed Personalized Heart Failure Interventions: The ALLEVIATE-HF Trial.

Abstract (English)

BACKGROUND: Early identification of worsening heart failure (HF) may improve outcomes. OBJECTIVES: This study aims to assess if insertable cardiac monitor (ICM)-based high-risk detection combined with centrally managed, nurse-facilitated, individually protocolized diuretic interventions is safe and improves HF outcomes. METHODS: A Reveal LINQ (Medtronic) ICM with an investigational HF risk-status software was implanted in participants with HF who were randomized 1:1 to an intervention arm (high-risk HF alert triggering protocolized diuretic regimen) or an observation arm (standard care). The primary safety endpoint was intervention-related serious adverse events and the primary efficacy endpoint was a 5-component hierarchical composite including cardiovascular death or HF hospitalization or outpatient HF event within 60 days of high-risk onset, Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, and 6-minute walk distance, analyzed using win ratio. RESULTS: A total of 711 participants were randomized (357 intervention, 354 observation). The primary composite endpoint did not significantly differ between groups (win ratio: 0.79; 95% CI: 0.62-1.01; P = 0.06). Over a mean follow-up of 17.3 ± 8.9 months, the serious adverse events rate was 0.32% (95% CI: 0.10%-0.99%; prespecified safety threshold ≤5%). The cumulative cardiovascular death and HF events were numerically higher in the intervention group (HR: 1.43; 95% CI: 0.95-2.15; P = 0.091). In an exploratory sensitivity analysis adjusting for a baseline Kansas City Cardiomyopathy Questionnaire imbalance, the win ratio was 1.02 (95% CI: 0.80-1.31; P = 0.85). CONCLUSIONS: ICM-based risk status detection with centrally coordinated diuretic intervention was safe and yielded a neutral result for the primary composite outcome under the tested implementation strategy (ALLEVIATE-HF [Algorithm Using LINQ Sensors for Evaluation and Treatment of Heart Failure]; NCT04452149).