Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: the Weight Monitoring in Heart Failure (WHARF) trial.
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.
Goldberg
Lee R
LR
Division of Cardiovascular Medicine, Heart Failure and Cardiac Transplant Program, University of Pennsylvania, Philadelphia, Pa 19104, USA. Lee.Goldberg@UPHS.UPENN.EDU
Piette
John D
JD
Walsh
Mary Norine
MN
Frank
Theodore A
TA
Jaski
Brian E
BE
Smith
Andrew L
AL
Rodriguez
Raymond
R
Mancini
Donna M
DM
Hopton
Laurie A
LA
Orav
E John
EJ
Loh
Evan
E
D001835:Body Weight; D002985:Clinical Protocols; D004582:Electronics, Medical; D004632:Emergency Medical Services; D005260:Female; D006300:Health Services Misuse / Q000706:statistics & numerical data*; D006333:Heart Failure / Q000401:mortality* / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000295:instrumentation* / Q000379:methods; D010359:Patient Readmission; D011446:Prospective Studies; D011788:Quality of Life