晚期心力衰竭患者每日电子家庭监测系统的随机试验：心力衰竭体重监测（WHARF）试验

Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: the Weight Monitoring in Heart Failure (WHARF) trial.

作者信息

Goldberg Lee R, Piette John D, Walsh Mary Norine, Frank Theodore A, Jaski Brian E, Smith Andrew L, Rodriguez Raymond, Mancini Donna M, Hopton Laurie A, Orav E John, Loh Evan

机构信息

Division of Cardiovascular Medicine, Heart Failure and Cardiac Transplant Program, University of Pennsylvania, Philadelphia, Pa 19104, USA.

出版信息

Am Heart J. 2003 Oct;146(4):705-12. doi: 10.1016/S0002-8703(03)00393-4.

DOI:10.1016/S0002-8703(03)00393-4

PMID:14564327

Abstract

BACKGROUND

Heart failure treatment guidelines emphasize daily weight monitoring for patients with heart failure, but data to support this practice are lacking. Using a technology-based heart failure monitoring system, we determined whether daily reporting of weight and symptoms in patients with advanced heart failure would reduce rehospitalization and mortality rates despite aggressive guideline-driven heart failure care.

METHODS

This was a randomized, controlled trial. Patients hospitalized with New York Heart Association class III or IV heart failure, with a left ventricular ejection fraction < or =35% were randomized to receive heart failure program care or heart failure program care plus the AlereNet system (Alere Medical, Reno, Nev) and followed-up for 6 months. The primary end point was 6-month hospital readmission rate. Secondary end points included mortality, heart failure hospitalization readmission rate, emergency room visitation rate, and quality of life.

RESULTS

Two hundred eighty patients from 16 heart failure centers across the United States were randomized: 138 received the AlereNet system and 142 received standard care. Mean age was 59 +/- 15 years and 68% were male. The population had very advanced heart failure, New York Heart Association class III (75%) or IV (25%), as evidenced by serum norepinepherine levels, 6-minute walk distance and outcomes. No differences in hospitalization rates were observed. There was a 56.2% reduction in mortality (P <.003) for patients randomized to the AlereNet group.

CONCLUSIONS

This is the largest multicenter, randomized trial of a technology-based daily weight and symptom-monitoring system for patients with advanced heart failure. Despite no difference in the primary end point of rehospitalization rates, mortality was significantly reduced for patients randomized to the AlereNet system without an increase in utilization, despite specialized and aggressive heart failure care in both groups.

摘要

背景

心力衰竭治疗指南强调对心力衰竭患者进行每日体重监测，但缺乏支持这一做法的数据。我们使用基于技术的心力衰竭监测系统，确定尽管有积极的指南驱动的心力衰竭护理措施，但晚期心力衰竭患者每日报告体重和症状是否会降低再住院率和死亡率。

方法

这是一项随机对照试验。因纽约心脏病协会III或IV级心力衰竭住院、左心室射血分数≤35%的患者被随机分为接受心力衰竭项目护理或心力衰竭项目护理加AlereNet系统（内华达州里诺市的Alere Medical公司），并随访6个月。主要终点是6个月的再住院率。次要终点包括死亡率、心力衰竭住院再住院率、急诊室就诊率和生活质量。

结果

来自美国16个心力衰竭中心的280名患者被随机分组：138名接受AlereNet系统，142名接受标准护理。平均年龄为59±15岁，68%为男性。该人群心力衰竭非常严重，纽约心脏病协会III级（75%）或IV级（25%），血清去甲肾上腺素水平、6分钟步行距离和预后均证明了这一点。未观察到住院率有差异。随机分组到AlereNet组的患者死亡率降低了56.2%（P<.003）。