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

May 16, 2012 updated by: NxStage Medical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 4 consecutive hours (+/- 30 minutes)
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 Frame: Time from admission to endpoint achievement
Time from admission to endpoint achievement
Total Volume Removal During the Intervention Period
Time Frame: Intervention start to end.
Intervention start to end.
Volume Removal Rate.
Time Frame: Intervention start to end.
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
Time Frame: Hospital discharge to 90 days after discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NxStage Medical

Investigators

  • Study Director: Alan Hull, MD, NxStage Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (Estimate)

February 8, 2006

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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