Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00319384|
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : April 27, 2006
Last Update Posted : October 4, 2012
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 or disease||Intervention/treatment|
|Congestive Heart Failure||Device: Ultrafiltration therapy|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Outpatient Ultrafiltration Therapy in Heart Failure Feasibility Trial|
|Study Start Date :||April 2006|
|Estimated Study Completion Date :||May 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319384
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|Principal Investigator:||Bradley Bart, MD||Hennepin Faculty Associates|