Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Outpatient Ultrafiltration Therapy in Heart Failure Feasibility Trial

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: Ultrafiltration therapy


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ultrafiltration therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 
| The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congestive heart failure, heart failure, ultrafiltration therapy, fluid overload