Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

October 3, 2012 updated by: Hennepin Healthcare Research Institute

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

Withdrawn

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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:

    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.

      -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Efficacy
The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Bradley Bart, MD, Hennepin Faculty Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Anticipated)

May 1, 2007

Study Registration Dates

First Submitted

April 26, 2006

First Submitted That Met QC Criteria

April 26, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 3, 2012

Last Verified

October 1, 2012

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.

Clinical Trials on Congestive Heart Failure

Clinical Trials on Ultrafiltration therapy

3
Subscribe