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J Am Coll Cardiol, 2007; 49:675-683, doi:10.1016/j.jacc.2006.07.073
(Published online 25 January 2007). © 2007 by the American College of Cardiology Foundation |
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,4,3
* Midwest Heart Foundation, Lombard, Illinois
John D. Dingell VA Medical Center, Division of Cardiology, Department of Medicine, Wayne State University, Detroit, Michigan
Division of Cardiology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
Division of Cardiology, Department of Medicine, Hennepin County Medical Center, Minneapolis, Minnesota
|| San Francisco Veterans Affairs Medical Center/University of California, San Francisco, California
¶ San Diego Cardiac Center, Sharp Memorial Hospital, San Diego, California
# Division of Cardiology, Department of Medicine, Brigham and Women’s Hospital, Harvard University, Boston, Massachusetts
** Division of Cardiology, Department of Medicine, University of Maryland, Baltimore, Maryland
Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio
Division of Cardiology, Department of Medicine, University of Chicago, Chicago, Illinois
CHF Solutions, Brooklyn Park, Minnesota
Manuscript received April 10, 2006; revised manuscript received June 9, 2006, accepted July 6, 2006.
* Reprint requests and correspondence: Dr. Maria Rosa Costanzo, Midwest Heart Foundation, Edward Heart Hospital, 4th Floor, 801 South Washington Street, P.O. Box 3226, Naperville, Illinois 60566. (Email: mcostanzo{at}midwestheart.com).
Partially presented as a Late Breaking Clinical Trial at the 55th Scientific Sessions of the American College of Cardiology, March 11–14, 2006, Atlanta, Georgia.
Objectives: This study was designed to compare the safety and efficacy of veno-venous ultrafiltration and standard intravenous diuretic therapy for hypervolemic heart failure (HF) patients.
Background: Early ultrafiltration may be an alternative to intravenous diuretics in patients with decompensated HF and volume overload.
Methods: Patients hospitalized for HF with 
2 signs of hypervolemia were randomized to ultrafiltration or intravenous diuretics. Primary end points were weight loss and dyspnea assessment at 48 h after randomization. Secondary end points included net fluid loss at 48 h, functional capacity, HF rehospitalizations, and unscheduled visits in 90 days. Safety end points included changes in renal function, electrolytes, and blood pressure.
Results: Two hundred patients (63 ± 15 years, 69% men, 71% ejection fraction 
40%) were randomized to ultrafiltration or intravenous diuretics. At 48 h, weight (5.0 ± 3.1 kg vs. 3.1 ± 3.5 kg; p = 0.001) and net fluid loss (4.6 vs. 3.3 l; p = 0.001) were greater in the ultrafiltration group. Dyspnea scores were similar. At 90 days, the ultrafiltration group had fewer patients rehospitalized for HF (16 of 89 [18%] vs. 28 of 87 [32%]; p = 0.037), HF rehospitalizations (0.22 ± 0.54 vs. 0.46 ± 0.76; p = 0.022), rehospitalization days (1.4 ± 4.2 vs. 3.8 ± 8.5; p = 0.022) per patient, and unscheduled visits (14 of 65 [21%] vs. 29 of 66 [44%]; p = 0.009). No serum creatinine differences occurred between groups. Nine deaths occurred in the ultrafiltration group and 11 in the diuretics group.
Conclusions: In decompensated HF, ultrafiltration safely produces greater weight and fluid loss than intravenous diuretics, reduces 90-day resource utilization for HF, and is an effective alternative therapy. (The UNLOAD trial; http://clinicaltrials.gov/ct/show/NCT00124137?order=1; NCT00124137 [ClinicalTrials.gov] ).
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