Back to resultsOutpatient Ultrafiltration Therapy in Heart Failure Patients Trial
Primary Purpose
Congestive Heart Failure
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrafiltration therapy
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring congestive heart failure, heart failure, ultrafiltration therapy, fluid overload
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: 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 Exclusion Criteria: 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. -
Sites / Locations
- Hennepin County Medical Center
Outcomes
Primary Outcome Measures
Efficacy
The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00319384
First Posted
April 26, 2006
Last Updated
October 3, 2012
Sponsor
Hennepin Healthcare Research Institute
Collaborators
Nuwellis, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00319384
Brief Title
Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial
Official Title
Outpatient Ultrafiltration Therapy in Heart Failure Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hennepin Healthcare Research Institute
Collaborators
Nuwellis, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
congestive heart failure, heart failure, ultrafiltration therapy, fluid overload
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Ultrafiltration therapy
Primary Outcome Measure Information:
Title
Efficacy
Title
The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration.
Secondary Outcome Measure Information:
Title
Quality of life will be assessed by the NYHA classification at 48 hours.
Title
Likert scales addressing global heart failure and shortness of breath symptoms at 48 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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:
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
Exclusion Criteria:
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Bart, MD
Organizational Affiliation
Hennepin Faculty Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16325039
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.
Results Reference
background
Learn more about this trial
Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial
We'll reach out to this number within 24 hrs