Status:
COMPLETED
Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
Lead Sponsor:
NxStage Medical
Conditions:
Heart Failure
CHF
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 patien...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00288587
Start Date
October 1 2003
End Date
January 1 2009
Last Update
June 19 2012
Active Locations (1)
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1
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195