Phase 4 N=36 Randomized Treatment

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

Heart Failure · CHF

Bottom Line

View on ClinicalTrials.gov: NCT00288587 ↗

Enrolled (actual)

Serious AEs

22.2%

Results posted

Jun 2012

Primary outcome: Primary: Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period. — 22.0; 34.8 hours

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: IV loop diuretic (Drug); NxStage System One (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NxStage Medical
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.	22.0; 34.8	—
SECONDARY Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.	3.63; 3.56; 6.98; 18.93	—
SECONDARY Total Volume Removal During the Intervention Period	5215; 2167	—
SECONDARY Volume Removal Rate.	3.4; 0.7	—
SECONDARY Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths	12; 10	—

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.

Eligibility 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 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

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Data sourced from ClinicalTrials.gov (NCT00288587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.