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Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

This study has been withdrawn prior to recruitment.
( Lack of enrollment )

Sponsors and Collaborators: Minneapolis Medical Research Foundation
CHF Solutions
Information provided by: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00319384
  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

MedlinePlus related topics:   Heart Failure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Outpatient Ultrafiltration Therapy in Heart Failure Feasibility Trial

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.

Estimated Enrollment:   10
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

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:

Study ID Numbers:   HSR 06-2642
First Received:   April 26, 2006
Last Updated:   April 20, 2007
ClinicalTrials.gov Identifier:   NCT00319384
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2008




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