Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

NCT00319384 | Withdrawn

• 1 other identifier: HSR 06-2642
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

congestive heart failure; heart failure; ultrafiltration therapy; fluid overload

Outcome Measures

Primary Outcomes (2)

• Efficacy

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

Secondary Outcomes (2)

• 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.

Interventions

Ultrafiltration therapy DEVICE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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• 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.

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• Nuwellis, Inc.: collaborator

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

• 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.

  PMID: 16325039 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Edema

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bradley Bart, MD

  Hennepin Faculty Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2006
• First Posted: April 27, 2006
• Study Start: April 1, 2006
• Study Completion: May 1, 2007
• Last Updated: October 4, 2012

Record last verified: 2012-10

Locations

US (1)