Outpatient Ultrafiltration Therapy in Heart Failure Patients Trial

Sponsor

Hennepin Healthcare Research Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00319384

Collaborator

Nuwellis, Inc. (Industry)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Device: Ultrafiltration therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Outpatient Ultrafiltration Therapy in Heart Failure Feasibility Trial

Study Start Date :

Apr 1, 2006

Anticipated Study Completion Date :

May 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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