NCT00288587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

June 19, 2012

Completed
Last Updated

June 19, 2012

Status Verified

May 1, 2012

Enrollment Period

4.9 years

First QC Date

February 6, 2006

Results QC Date

May 16, 2012

Last Update Submit

May 16, 2012

Conditions

Heart FailureCHF

Keywords

Heart FailureCongestive Heart FailureCHF

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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.

    Intervention start to end.

  • Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths

    Hospital discharge to 90 days after discharge

Study Arms (2)

Ultrafiltration

ACTIVE COMPARATOR

Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.

Device: NxStage System One

Usual & Customary

ACTIVE COMPARATOR

Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.

Drug: IV loop diuretic

Interventions

IV loop diureticDRUG

Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.

Usual & Customary
NxStage System OneDEVICE

Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.

Ultrafiltration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

  • 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.

    PMID: 22277179RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Sodium Potassium Chloride Symporter Inhibitors

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Membrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesDiureticsNatriuretic AgentsPhysiological Effects of Drugs

Results Point of Contact

Title
Leighann Cesar, RN
Organization
Cleveland Clinic Foundation
cesar1@ccf.org
216-445-6551

Study Officials

  • Alan Hull, MD

    NxStage Medical

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 8, 2006

Study Start

October 1, 2003

Primary Completion

September 1, 2008

Study Completion

January 1, 2009

Last Updated

June 19, 2012

Results First Posted

June 19, 2012

Record last verified: 2012-05

Locations

US(1)