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Completed

NCT Number: NCT00288587

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.

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Key information

Conditions

Heart Failure CHF Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV loop diuretic

Drug

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

NxStage System One

Device

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

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.

    Time frame: 4 consecutive hours (+/- 30 minutes)

Secondary outcomes

  1. Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.

    Time frame: Time from admission to endpoint achievement

  2. Total Volume Removal During the Intervention Period

    Time frame: Intervention start to end.

  3. Volume Removal Rate.

    Time frame: Intervention start to end.

    Hours of therapy required to remove 1 liter of fluid normalized to body weight.

  4. 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.

Sponsors and collaborators

Lead sponsor

NxStage Medical

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Feb 8, 2006
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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