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

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	Device: NxStage System One	Phase IV

MedlinePlus related topics:

Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by NxStage Medical:

Primary Outcome Measures:

Time required for the 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 ]
Less than or equal to 18 mm HG 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 of intervention period, length of time in a specialized heart failure unit, length of hospital stay, total volume removed, required prescription changes and changes in patient status relative to baseline. [ Time Frame: Time to Discharge from Hospital ] [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	October 2003
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.	Device: NxStage System One 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.
2: Active Comparator 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.	Device: NxStage System One 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.

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

Responsible Party:	NxStage Medical, Inc. ( Paul Clark, Director of Clinical and Regulatory Affairs )
Study ID Numbers:	CP0007
First Received:	February 6, 2006
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00288587
Health Authority:	United States: Institutional Review Board

Keywords provided by NxStage Medical:

Heart Failure

Congestive Heart Failure

CHF

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	NxStage Medical
Information provided by:	NxStage Medical
ClinicalTrials.gov Identifier:	NCT00288587