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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NxStage Medical
• Treatments: Diuretics; Sodium Potassium Chloride Symporter Inhibitors

Criteria

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