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

Completed · Phase 4

Conditions studied: Heart Failure, CHF

In brief

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.

Key facts

Study ID

NCT00288587

Run by

NxStage Medical

People needed

36

Starts

2003-10-01

Expected to finish

2009-01-01

Last updated by the study team

2012-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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