Butler Javed, Kahwash Rami, Khan Muhammad Shahzeb, Gerritse Bart, Laechelt Aimee, Wehking Jennifer, Sarkar Shantanu, van Dorn Brian, Laager Verla, Patel Nirav, Zile Michael R
Baylor Scott and White Research Institute, Dallas, TX, USA.
University of Mississippi Medical Center, Jackson, MS, USA.
Eur J Heart Fail. 2025 Apr;27(4):697-706. doi: 10.1002/ejhf.3595. Epub 2025 Jan 27.
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.
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.
ALLEVIATE-HF will evaluate how ICM-based HF management can impact the outcomes of patients with HF regardless of ejection fraction.
早期识别和处理心力衰竭（HF）病情恶化对于预防疾病进展和住院治疗至关重要。ALLEVIATE-HF（使用LINQ传感器评估和治疗心力衰竭的算法）试验是一项前瞻性、随机、对照、双盲、多中心试验，旨在评估使用Reveal LINQ™植入式心脏监测器（ICM）对HF患者持续监测和评估HF风险状态并指导及时干预的安全性和有效性。
ICM算法使用来自心电图（心房颤动[AF]、AF期间的心室率、心率变异性和夜间心率）、三轴加速度计（患者活动时长）和皮下生物阻抗（液体量、呼吸频率）的参数。该试验将招募约760例纽约心脏病协会II级或III级HF患者，这些患者近期因HF住院或在门诊需要静脉利尿剂治疗或利钠肽水平升高，且未植入心脏植入式电子设备或血流动力学监测器。患者被随机分为观察组或干预组，后者将接受一种干预途径，由远程护士在高风险时实施个体化的按需（PRN或“根据需要”）4天药物干预以进行急性容量管理。在随机随访13个月后，所有患者进入非盲的延长随访阶段，在高风险时进行PRN干预。该研究的主要分层综合终点包括心血管死亡、HF事件、堪萨斯城心肌病问卷评分和6分钟步行试验距离。
ALLEVIATE-HF将评估基于ICM的HF管理如何影响HF患者的结局，无论其射血分数如何。
