Clinical trial NCT00288587: Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
Official title: CP0007: Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
CHF
Keywords: Heart Failure
Congestive Heart Failure
CHF
Lead sponsor: NxStage Medical
Sponsor class: OTHER
First posted: 2006-02-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 \<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

Primary outcomes:
measure: 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.
timeFrame: 4 consecutive hours (+/- 30 minutes)
Secondary outcomes:
measure: Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.
timeFrame: Time from admission to endpoint achievement
measure: Total Volume Removal During the Intervention Period
timeFrame: Intervention start to end.
measure: Volume Removal Rate.
timeFrame: Intervention start to end.
measure: Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths
timeFrame: Hospital discharge to 90 days after discharge
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: NxStage Medical
name: Alan Hull, MD
role: STUDY_DIRECTOR
References:
citation: Hanna MA, Tang WH, Teo BW, O'Neill JO, Weinstein DM, Lau SM, Van Lente F, Starling RC, Paganini EP, Taylor DO. Extracorporeal ultrafiltration vs. conventional diuretic therapy in advanced decompensated heart failure. Congest Heart Fail. 2012 Jan-Feb;18(1):54-63. doi: 10.1111/j.1751-7133.2011.00231.x. Epub 2011 Jul 20.