Author + information
- Received April 10, 2006
- Revision received June 9, 2006
- Accepted July 6, 2006
- Published online February 13, 2007.
- Maria Rosa Costanzo, MD, FACC⁎,1,⁎ (, )
- Maya E. Guglin, MD, FACC†,
- Mitchell T. Saltzberg, MD, FACC⁎,2,
- Mariell L. Jessup, MD, FACC‡,
- Bradley A. Bart, MD, FACC§,
- John R. Teerlink, MD, FACC∥,
- Brian E. Jaski, MD, FACC¶,
- James C. Fang, MD, FACC#,
- Erika D. Feller, MD, FACC⁎⁎,
- Garrie J. Haas, MD, FACC††,
- Allen S. Anderson, MD, FACC‡‡,
- Michael P. Schollmeyer, DVM§§,4,
- Paul A. Sobotka, MD, FACC§§,3,
- UNLOAD Trial Investigators
- ↵⁎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.
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).
↵1 Dr. Costanzo is a member of the Medical Advisory Board of CHF Solutions, has CHF Solutions stock options as compensation for Medical Advisory Board membership, and receives speaker’s honoraria from CHF Solutions.
↵2 Dr. Saltzberg is a consultant for CHF Solutions and receives speaker’s honoraria from CHF Solutions.
↵3 Dr. Sobotka is Chief Medical Officer for CHF Solutions Inc.
↵4 Dr. Schollmeyer is Director of Clinical Affairs for CHF Solutions Inc.
This study was supported by CHF Solutions Inc., Brooklyn Park, Minnesota.
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.
- Received April 10, 2006.
- Revision received June 9, 2006.
- Accepted July 6, 2006.
- American College of Cardiology Foundation