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This study has been withdrawn prior to enrollment.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

April 26, 2006
October 3, 2012
April 2006
Not Provided
  • Efficacy
  • The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration.
Same as current
Complete list of historical versions of study NCT00319384 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial
Outpatient Ultrafiltration Therapy in Heart Failure Feasibility Trial

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Congestive Heart Failure
Device: Ultrafiltration therapy
Not Provided
Bart BA, Boyle A, Bank AJ, Anand I, Olivari MT, Kraemer M, Mackedanz S, Sobotka PA, Schollmeyer M, Goldsmith SR. Ultrafiltration versus usual care for hospitalized patients with heart failure: the Relief for Acutely Fluid-Overloaded Patients With Decompensated Congestive Heart Failure (RAPID-CHF) trial. J Am Coll Cardiol. 2005 Dec 6;46(11):2043-6. Epub 2005 Nov 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2007
Not Provided

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.

      -

Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00319384
HSR 06-2642
No
Not Provided
Minneapolis Medical Research Foundation
CHF Solutions
Principal Investigator: Bradley Bart, MD Hennepin Faculty Associates
Minneapolis Medical Research Foundation
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP