Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-05-31

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.

Conditions

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Congestive Heart Failure

Keywords

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congestive heart failure heart failure ultrafiltration therapy fluid overload

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ultrafiltration therapy

Intervention Type DEVICE

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:

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

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.

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Bradley Bart, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin Faculty Associates

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 16325039 (View on PubMed)

Other Identifiers

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HSR 06-2642

Identifier Type: -

Identifier Source: org_study_id