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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure, CHF

Intervention / Treatment
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* Drug: IV loop diuretic
* Device: NxStage System One


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrafiltration<br>Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure. | Device: NxStage System One<br>* Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.<br>|
| Active Comparator: Usual & Customary<br>Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure. | Drug: IV loop diuretic<br>* Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 4 consecutive hours (+/- 30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. |  | Time from admission to endpoint achievement | 
| Total Volume Removal During the Intervention Period |  | Intervention start to end. | 
| Volume Removal Rate. | Hours of therapy required to remove 1 liter of fluid normalized to body weight. | Intervention start to end. | 
| 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. | Hospital discharge to 90 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Congestive Heart Failure, CHF