Congestive Heart Failure
Conditions
Keywords
congestive heart failure, heart failure, ultrafiltration therapy, fluid overload
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.
Interventions
DEVICEUltrafiltration therapy
Sponsors
Nuwellis, Inc.
Hennepin Healthcare Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | — |
| The primary efficacy endpoint is weight loss measured immediately and 48 hours after ultrafiltration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed