Status:
WITHDRAWN
Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial
Lead Sponsor:
Hennepin Healthcare Research Institute
Collaborating Sponsors:
Nuwellis, Inc.
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18-90 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- Patients will be recruited from the cardiology clinic at Hennepin County Medical Center. Patients are eligible for the study if they are:
- Older than 18
- Not pregnant
- Have heart failure with worsening hypervolemia despite oral diuretics
- 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
- Not more than 10 kg above their usual baseline weight
- Have, in the opinion of the treating physician, a need for a minimum of 2 liters of volume removal
Exclusion
- <!-- -->
- Systolic blood pressure \< 90 mmHg
- Serum creatinine \> 3.0 mg/dL
- Hematocrit \>45 %
- Uncontrolled arrhythmias
- Need for hospitalization
- Require renal replacement therapy
- Contraindication to anticoagulation with heparin
- Poor venous access.
- \-
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00319384
Start Date
April 1 2006
End Date
May 1 2007
Last Update
October 4 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415