Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

Not Applicable

Withdrawn

• Conditions: Congestive Heart Failure

• Registration Number: NCT00319384
• Lead Sponsor: Hennepin Healthcare Research Institute

Brief 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.

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-26
• Study First Submitted QC: 2006-04-26
• Study First Posted: 2006-04-27
• Study Completion: 2007-05
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy
The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States