- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00319384
Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial
Outpatient Ultrafiltration Therapy in Heart Failure Feasibility 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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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 Criteria:
- 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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Efficacy
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The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration.
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Secondary Outcome Measures
Outcome Measure |
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Quality of life will be assessed by the NYHA classification at 48 hours.
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Likert scales addressing global heart failure and shortness of breath symptoms at 48 hours.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bradley Bart, MD, Hennepin Faculty Associates
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSR 06-2642
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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