Elsevier

American Heart Journal

Volume 146, Issue 4, October 2003, Pages 705-712
American Heart Journal

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

https://doi.org/10.1016/S0002-8703(03)00393-4Get rights and content

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 ≤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.

Section snippets

Study population

Patients hospitalized with New York Heart Association (NYHA) class III or IV heart failure, with a left ventricular ejection fraction, measured within 6 months of enrollment, of ≤35% were eligible for enrollment. These patients had to weigh <400 pounds (scale limit), have the ability to stand for at least 20 seconds without holding the wall, and speak either English or Spanish.

Patients were recruited from 16 clinical sites throughout the continental United States (8 cardiac transplant centers

Results

From July 1998 through December 2000, a total of 280 patients from 16 medical centers across the United States underwent randomization: 138 received the AlereNet system plus standard heart failure care and 142 were assigned to receive standard heart failure care. The mean age of the population was 59 ± 15 years and 68% were male. The mean follow-up period was 169 ± 51 days. During the study, 32 patients either refused follow-up data collection or were lost to follow-up. Seven patients received

Discussion

This study is the first multicenter, prospective, randomized, controlled clinical trial to examine the effect of a technology-based heart failure daily weight and symptom management system on hospitalization rates, mortality, and quality of life in patients hospitalized with advanced heart failure (ie, as measured by plasma norepinepherine levels, 6-minute walk distance, ejection fraction, serum sodium and creatinine and outcomes). Although not designed as a mortality study, we demonstrated

Acknowledgements

We thank Dr Mariell Jessup for her thoughtful editorial review of this manuscript.

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Supported by grants from Alere Medical, Incorporated.

*

The centers and investigators participating in the WHARF trial are listed in the Appendix.

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