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

NxStage Medical

Status and phase: Completed; Phase 4

Conditions: CHF; Heart Failure

Treatments: Device: NxStage System One; Drug: IV loop diuretic

Study type: Interventional

Funder types: Other

Identifiers

NCT00288587

CP0007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Ultrafiltration

Active Comparator group

Description:

Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.

Treatment:

Device: NxStage System One

Usual & Customary

Active Comparator group

Description:

Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.

Treatment:

Drug: IV loop diuretic