Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

Congestive Heart Failure Clinical Trial

Official title:

Outpatient Ultrafiltration Therapy in Heart Failure Feasibility Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00319384
• Other study ID #: HSR 06-2642
• Status: Withdrawn
• Phase: N/A
• First received: April 26, 2006
• Last updated: October 3, 2012
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: October 2012
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Ultrafiltration therapy

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation	CHF Solutions

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy
Primary	The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration.
Secondary	Quality of life will be assessed by the NYHA classification at 48 hours.
Secondary	Likert scales addressing global heart failure and shortness of breath symptoms at 48 hours.