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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288587
• Other study ID #: CP0007
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2006
• Last updated: May 16, 2012
• Start date: October 2003
• Est. completion date: January 2009

Study information

• Verified date: May 2012
• Source: NxStage Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• CHF
• Heart Failure

Intervention

Drug:
• IV loop diuretic
Use of conventional diuretic therapy 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.

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
NxStage Medical

Country where clinical trial is conducted

United States, 

References & 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.		Time from admission to endpoint achievement	No
Secondary	Total Volume Removal During the Intervention Period		Intervention start to end.	No
Secondary	Volume Removal Rate.	Hours of therapy required to remove 1 liter of fluid normalized to body weight.	Intervention start to end.	No
Secondary	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	No