Document Type
Article
Publication Title
Journal of the American College of Cardiology
Abstract
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).
First Page
3592
Last Page
3607
DOI
10.1016/j.jacc.2026.03.075
Publication Date
6-30-2026
Recommended Citation
Butler J, Kahwash R, Khan MS, Zhang D, Dukes JW, Reddy M, Basuray A, Gharib E, Gerritse B, Laechelt A, Wehking J, Sarkar S, Van Dorn B, Patel N, Laager V, Zile MR; ALLEVIATE-HF Investigators. Risk-Based Nurse-Managed Personalized Heart Failure Interventions: The ALLEVIATE-HF Trial. J Am Coll Cardiol. 2026 Jun 30;87(25):3592-3607. doi: 10.1016/j.jacc.2026.03.075. Epub 2026 May 27. PMID: 42201288.