Study Objective: The purpose of this study was to assess the long term (three months) safety and efficacy of ultrafiltration, as performed with Aquadex FlexFlow in the reduction of fluid overload in patients hospitalized for acute decompensated heart failure (adCHF).

Enrollment: 200 patients equally randomized to UF alone or IV diuretics (Control).

Clinical Sites: Up to 30 clinical sites with a significant heart failure population hospitalized for fluid overload and experienced in fluid management with Aquadex FlexFlow.

Study Design: The study is a prospective, randomized, controlled multi-center trial comparing Aquadex FlexFlow alone to usual medical therapy in the management of patients admitted to the hospital for adCHF and fluid overload.

Study Population: Patients hospitalized with adCHF and fluid overload.

Primary Efficacy Endpoints:

• Total weight loss during the first 48 hours from randomization into the trial.
• Dyspnea score during the first 48 hours from randomization.

Primary Safety Endpoints:

• Changes in serum BUN and creatinine
• Changes in serum electrolytes
• Number of hypotensive events during treatments

Secondary Endpoints:

• Secondary endpoints were assessed at selective time periods at baseline, during their treatments and at post-treatment intervals.
• Total net fluid loss during the first 48 hours from randomization into the trial.
• Quality of Life Questionnaire (“Living with Heart Failure” University of Minnesota)
• Changes in BNP levels.
• Changes in cardiac functional class (NYHA)
• Type and doses of oral diuretics.
• Six Minute Walk Test
• Global Assessment

Financial Outcomes:

• Hospital length of stay (LOS).
• Number of hospital readmissions for congestive heart failure with fluid overload during the first 30 days after discharge from the hospital for adCHF.

Exploratory Endpoints:

1. Days alive after hospitalization

The Aquadex FlexFlow® Indication

The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy; and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload, who have failed diuretic therapy and require hospitalization. All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.