Outpatient Ultrafiltration Therapy in Heart Failure Patients 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.
|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|
- The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration.
- 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.
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||May 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319384
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|Principal Investigator:||Bradley Bart, MD||Hennepin Faculty Associates|