NCT00288587

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

CP0007: Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: NxStage Medical · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• CHF

Interventions

Type	Name	Description
DRUG	IV loop diuretic	Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
DEVICE	NxStage System One	Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.

Timeline

• Start date: 2003-10-01
• Primary completion: 2008-09-01
• Completion: 2009-01-01
• First posted: 2006-02-08
• Last updated: 2012-06-19
• Results posted: 2012-06-19

Locations

1 site across 1 country: United States