Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00319384
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : April 27, 2006
Last Update Posted : October 4, 2012
CHF Solutions
Information provided by:
Minneapolis Medical Research Foundation

Brief Summary:

This trial will look at the effectiveness and patient acceptance of ultrafiltration therapy in an outpatient setting.

The purpose of this study is to determine if ambulatory patients who suffer from heart failure and hypervolemia can be safely and effectively treated in an outpatient infusion clinic. The results from this trial will be useful in planning a larger, randomized trial comparing usual care and ultrafiltration for this patient population in similar ambulatory settings.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Device: Ultrafiltration therapy Not Applicable

Detailed Description:
This is a pilot study to assess the feasibility, effectiveness, safety and patient acceptance of ultrafiltration in ambulatory patients with heart failure and hypervolemia. The results will be useful in planning a larger clinical trial.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outpatient Ultrafiltration Therapy in Heart Failure Feasibility Trial
Study Start Date : April 2006
Estimated Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Primary Outcome Measures :
  1. Efficacy
  2. The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration.

Secondary Outcome Measures :
  1. Quality of life will be assessed by the NYHA classification at 48 hours.
  2. Likert scales addressing global heart failure and shortness of breath symptoms at 48 hours.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients will be recruited from the cardiology clinic at Hennepin County Medical Center. Patients are eligible for the study if they are:

    1. Older than 18
    2. Not pregnant
    3. Have heart failure with worsening hypervolemia despite oral diuretics
    4. Have at least two of the following signs or symptoms of hypervolemia: JVD, edema >1+, rales pulmonary edema on chest x-ray, orthopnea or PND
    5. Not more than 10 kg above their usual baseline weight
    6. Have, in the opinion of the treating physician, a need for a minimum of 2 liters of volume removal

      Exclusion Criteria:

    1. Systolic blood pressure < 90 mmHg
    2. Serum creatinine > 3.0 mg/dL
    3. Hematocrit >45 %
    4. Uncontrolled arrhythmias
    5. Need for hospitalization
    6. Require renal replacement therapy
    7. Contraindication to anticoagulation with heparin
    8. Poor venous access.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00319384

United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
CHF Solutions
Principal Investigator: Bradley Bart, MD Hennepin Faculty Associates

Publications: Identifier: NCT00319384     History of Changes
Other Study ID Numbers: HSR 06-2642
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012

Keywords provided by Minneapolis Medical Research Foundation:
congestive heart failure
heart failure
ultrafiltration therapy
fluid overload

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases