UNLOAD study data suggest there are immediate and long-term benefits for patients hospitalized with heart failure who receive ultrafiltration therapy to treat fluid overload, according to a presentation at the annual meeting of the American College of Cardiology. The current study is the first randomized clinical trial to compare the safety and efficacy of a non-drug-based option with standard intravenous diuretic therapy.

The UNLOAD clinical trial (UltrafiltratioN versus IV Diuretics for Patients HospitaLized for Acute Decompensated Congestive Heart Failure) compared long-term safety and efficacy of adjunct ultrafiltration therapy with conventional drug therapy alone. Roughly 200 patients were enrolled at 28 medical sites. In the prospective trial, patients were randomized to the ultrafiltration group or the intravenous diuretics group, with all patients assessed at entry and at intervals out to 90 days.

Data show that patients hospitalized with heart failure who received ultrafiltration therapy lost more weight and experienced greater net fluid loss than patients treated primarily with intravenous diuretics. At 90 days, the ultrafiltration group had significantly fewer days in the hospital, rehospitalizations for heart failure, unscheduled heart failure-related office visits, and emergency room visits.

"The positive results of the UNLOAD trial demonstrate that ultrafiltration treatment can relieve fluid overload quickly, safely and predictably, as well as lead to sustained clinical benefits," said Principal Investigator Maria Rosa Costanzo, MD, Midwest Heart Specialists, Chicago, who presented the UNLOAD results.

Physicians' treatment options are no longer limited to the habitual and historical reliance solely on intravenous diuretics. This is an important breakthrough in the treatment of fluid overload."

Among the statistically significant findings are the following: After 48 hours of treatment, the ultrafiltration group had a 38-percent greater weight loss than standard care patients and a 28-percent greater net fluid loss.

At 90 days after hospital discharge, ultrafiltration patients had a 43-percent decrease in rehospitalizations for heart failure, a 50-percent reduction in total number of rehospitalizations, a 52-percent reduction in visits to emergency departments or clinics, and a 63-percent total reduction in hospital days after initial discharge.

Benefits in both weight loss and rehospitalization rate were seen in all subgroups analyzed.

"This important trial is an exciting milestone for CHF Solutions," said John Erb, chief executive officer of CHF Solutions, a Minneapolis-based medical device company and sponsor of the trial. In the UNLOAD trial, ultrafiltration was administered via Aquadex FlexFlow(TM), a system developed and manufactured by CHF Solutions.

Ultrafiltration performed with the Aquadex FlexFlow, a technologically sophisticated mechanical system, can remove up to a pound per hour of excess salt and water from the blood stream without clinically significant effects on kidney function, heart rate, blood pressure or electrolyte balance. The system is highly automated and used at many leading US medical centers and outpatient clinics. Standard catheters inserted into peripheral or central veins connect the patient to the device.