Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

This study has been withdrawn prior to enrollment.

( Lack of enrollment )

First Received on April 26, 2006. Last Updated on April 20, 2007 History of Changes

Sponsor:	Minneapolis Medical Research Foundation
Collaborator:	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

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:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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:

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.

ClinicalTrials.gov Identifier:	NCT00319384 History of Changes
Other Study ID Numbers:	HSR 06-2642
Study First Received:	April 26, 2006
Last Updated:	April 20, 2007
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
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2012