Back to resultsExtracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
Primary Purpose
Heart Failure, CHF
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV loop diuretic
NxStage System One
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Congestive Heart Failure, CHF
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
Sites / Locations
- The Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ultrafiltration
Usual & Customary
Arm Description
Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.
Total Volume Removal During the Intervention Period
Volume Removal Rate.
Hours of therapy required to remove 1 liter of fluid normalized to body weight.
Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths
Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00288587
Brief Title
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
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NxStage Medical
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, CHF
Keywords
Heart Failure, Congestive Heart Failure, CHF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrafiltration
Arm Type
Active Comparator
Arm Description
Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Arm Title
Usual & Customary
Arm Type
Active Comparator
Arm Description
Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
Intervention Type
Drug
Intervention Name(s)
IV loop diuretic
Intervention Description
Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
Intervention Type
Device
Intervention Name(s)
NxStage System One
Intervention Description
Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Primary Outcome Measure Information:
Title
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.
Time Frame
4 consecutive hours (+/- 30 minutes)
Secondary Outcome Measure Information:
Title
Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.
Time Frame
Time from admission to endpoint achievement
Title
Total Volume Removal During the Intervention Period
Time Frame
Intervention start to end.
Title
Volume Removal Rate.
Description
Hours of therapy required to remove 1 liter of fluid normalized to body weight.
Time Frame
Intervention start to end.
Title
Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths
Description
Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.
Time Frame
Hospital discharge to 90 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Hull, MD
Organizational Affiliation
NxStage Medical
Official's Role
Study Director
Facility Information:
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22277179
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.
Results Reference
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Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
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