Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

Withdrawn before enrolling · Not applicable

Conditions studied: Congestive Heart Failure

In brief

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.

Key facts

Study ID: NCT00319384
Run by: Hennepin Healthcare Research Institute
People needed: 0
Starts: 2006-04-01
Expected to finish: 2007-05-01
Last updated by the study team: 2012-10-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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