Continuous Risk Monitoring and Management of Heart Failure: Rationale and Design of the ALLEVIATE-HF Trial

AIMS: Early identification and management of worsening heart failure (HF) is necessary to prevent disease progression and hospitalizations. The ALLEVIATE-HF (Algorithm Using LINQ Sensors for Evaluation and Treatment of Heart Failure) trial is a prospective, randomized, controlled, double-blind, multicentre trial that aims to assess the safety and efficacy of using the Reveal LINQ™ insertable cardiac monitor (ICM) in patients with HF to continuously monitor and evaluate HF risk status and guide timely interventions. METHODS: The ICM algorithm uses parameters derived from electrocardiogram (atrial fibrillation [AF], ventricular rate during AF, heart rate variability, and night heart rate), three-axis accelerometer (patient activity duration), and subcutaneous bioimpedance (fluid volume, respiration rate). The trial will enroll ~760 patients with New York Heart Association class II or III HF with recent hospitalization for HF or needing intravenous diuretics in the outpatient setting or elevated natriuretic peptide levels, who do not have an implanted cardiac implantable electronic device or haemodynamic monitor. Patients are randomized to an observation or an intervention arm, where the latter will receive an intervention pathway with remote nurses implementing individualized pro re nata (PRN or 'as needed') 4-day medication interventions for acute volume management upon high risk. After 13 months of randomized follow-up, all patients enter an unblinded prolonged follow-up phase with PRN interventions upon high risk. The primary hierarchical composite endpoint for the study includes cardiovascular death, HF events, Kansas City Cardiomyopathy Questionnaire score, and 6-min walk test distance. CONCLUSION: ALLEVIATE-HF will evaluate how ICM-based HF management can impact the outcomes of patients with HF regardless of ejection fraction.