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Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

This study has been withdrawn prior to enrollment.
(Lack of enrollment)
Sponsor:
Collaborator:
CHF Solutions
Information provided by:
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00319384
First received: April 26, 2006
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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 Intervention
Congestive Heart Failure
Device: Ultrafiltration therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outpatient Ultrafiltration Therapy in Heart Failure Feasibility Trial

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

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

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

Enrollment: 0
Study Start Date: April 2006
Estimated Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

      -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319384

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

Publications:
ClinicalTrials.gov Identifier: NCT00319384     History of Changes
Other Study ID Numbers: HSR 06-2642
Study First Received: April 26, 2006
Last Updated: October 3, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014