Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)

Phase 4

Completed

Brief Summary: The purpose of this study is to assess the ability of Ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with NYHA class III/IV Heart Failure.

Detailed Description: This study will be preformed in a specialized heart failure unit at the Cleveland Clinic Foundation (CCF) and will include both the UF-treated group and a control group receiving usual and customary care. Patients will be stratified according to renal function at the time of admission. Therapies will be guided by specific hemodynamic criteria routinely used at the study institution.

Recruitment & Eligibility

Inclusion Criteria

Admitted to Heart Failure Unit (H-22) with NYHA class III/IV HF and pulmonary artery catheter in situ
Left ventricular ejection fraction <40%
Mean Pulmonary Artery Occlusion Pressure ≥20 mm Hg
Able to give informed consent

Exclusion Criteria

Currently on renal replacement therapy or determined to need renal replacement therapy at the time of enrollment
Estimated glomerular filtration rate (GFR) <15 mL/min
Systolic blood pressure (SBP) <80 mm Hg
Acute coronary syndrome
Hematocrit >50%
Malignancy other than prostrate or skin
Chronic edematous states other than HF, including nephritic syndrome and cirrhosis
Chronic inflammatory or infectious condition
Pregnancy
Previous enrollment in this study
Expectation of need for heart transplantation or cardiac assist device within one week
Pulmonary failure requiring intubation and mechanical ventilation
Known or suspected hypersensitivity to dialysis membranes
Severe aortic stenosis or regurgitation
Severe mitral stenosis

Arm && Interventions

Group	Intervention	Description
Ultrafiltration	NxStage System One	Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Usual & Customary	IV loop diuretic	Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.

Primary Outcome Measures

Name	Time	Method
Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.	4 consecutive hours (+/- 30 minutes)

Secondary Outcome Measures

Name	Time	Method
Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.	Time from admission to endpoint achievement
Total Volume Removal During the Intervention Period	Intervention start to end.
Volume Removal Rate.	Intervention start to end.	Hours of therapy required to remove 1 liter of fluid normalized to body weight.
Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths	Hospital discharge to 90 days after discharge	Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.