Clinical trial NCT00319384: Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial
Official title: Outpatient Ultrafiltration Therapy in Heart Failure Feasibility Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Congestive Heart Failure
Keywords: congestive heart failure
heart failure
ultrafiltration therapy
fluid overload
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Nuwellis, Inc.
First posted: 2006-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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: 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.

Eligibility criteria: Inclusion Criteria:

* Patients will be recruited from the cardiology clinic at Hennepin County Medical Center. Patients are eligible for the study if they are:

  1. Older than 18
  2. Not pregnant
  3. Have heart failure with worsening hypervolemia despite oral diuretics
  4. 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
  5. Not more than 10 kg above their usual baseline weight
  6. Have, in the opinion of the treating physician, a need for a minimum of 2 liters of volume removal

     Exclusion Criteria:

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  1. Systolic blood pressure \< 90 mmHg
  2. Serum creatinine \> 3.0 mg/dL
  3. Hematocrit \>45 %
  4. Uncontrolled arrhythmias
  5. Need for hospitalization
  6. Require renal replacement therapy
  7. Contraindication to anticoagulation with heparin
  8. Poor venous access.

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Primary outcomes:
measure: Efficacy
measure: The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration.
Secondary outcomes:
measure: Quality of life will be assessed by the NYHA classification at 48 hours.
measure: Likert scales addressing global heart failure and shortness of breath symptoms at 48 hours.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Faculty Associates
name: Bradley Bart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bart BA, Boyle A, Bank AJ, Anand I, Olivari MT, Kraemer M, Mackedanz S, Sobotka PA, Schollmeyer M, Goldsmith SR. Ultrafiltration versus usual care for hospitalized patients with heart failure: the Relief for Acutely Fluid-Overloaded Patients With Decompensated Congestive Heart Failure (RAPID-CHF) trial. J Am Coll Cardiol. 2005 Dec 6;46(11):2043-6. doi: 10.1016/j.jacc.2005.05.098. Epub 2005 Nov 4.