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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NxStage Medical
ClinicalTrials.gov Identifier:
NCT00288587
First received: February 6, 2006
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Heart Failure
CHF
Drug: IV loop diuretic
Device: NxStage System One
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CP0007: Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)

Resource links provided by NLM:


Further study details as provided by NxStage Medical:

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. [ Time Frame: 4 consecutive hours (+/- 30 minutes) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital. [ Time Frame: Time from admission to endpoint achievement ] [ Designated as safety issue: No ]
  • Total Volume Removal During the Intervention Period [ Time Frame: Intervention start to end. ] [ Designated as safety issue: No ]
  • Volume Removal Rate. [ Time Frame: Intervention start to end. ] [ Designated as safety issue: No ]
    Hours of therapy required to remove 1 liter of fluid normalized to body weight.

  • Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths [ Time Frame: Hospital discharge to 90 days after discharge ] [ Designated as safety issue: No ]
    Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.


Enrollment: 36
Study Start Date: October 2003
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ultrafiltration
Patients treated with Extracorporeal Ultrafiltration 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.
Other Name: NxStage System One
Active Comparator: Usual & Customary
Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
Drug: IV loop diuretic
Use of conventional diuretic therapy upon hospital admission for treatment of decompensated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288587

Locations
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
NxStage Medical
Investigators
Study Director: Alan Hull, MD NxStage Medical
  More Information

Publications:
Responsible Party: NxStage Medical
ClinicalTrials.gov Identifier: NCT00288587     History of Changes
Other Study ID Numbers: CP0007
Study First Received: February 6, 2006
Results First Received: May 16, 2012
Last Updated: May 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by NxStage Medical:
Heart Failure
Congestive Heart Failure
CHF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Diuretics
Sodium Potassium Chloride Symporter Inhibitors
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014