Overview

The objective of this feasibility study is to characterize the performance of CHF Solutions' ultrafiltration system, the Aquadex FlexFlow System with the hematocrit (HCT) feature in conjunction with Daxor's blood volume analyzer (BVA-100). Monitor blood volume changes during UF therapy as a potential mean to guide the removal of fluid in subjects hospitalized with acute decompensated heart failure (ADHF).

Eligibility

Inclusion Criteria:

1. Age 18 years or older
2. Subject or legally authorized representative is able to provide appropriate consent to participate
3. Hospitalized for ADHF with fluid overload as indicated by at least two of the following
4. Pitting edema 2+ of the lower extremities
5. Jugular venous distention > 8 cm
6. Pulmonary edema/pleural effusion on chest x-ray
7. Paroxysmal nocturnal dyspnea or two- pillow orthopnea
8. Respiration rate 20 per minute

Exclusion Criteria:

1. Unable or unwillingness to provide informed consent or to comply with study requirements
2. Subject who is pregnant
3. Acute coronary syndrome
4. Known bilateral renal artery stenosis
5. Serum creatinine > 3.0 mg/dL at the time of presentation
6. Subject receiving ongoing active treatment with diuretics (up to 2 doses of IV diuretics are permitted before initiation of ultrafiltration therapy)
7. Systolic blood pressure 90 mmHg
8. Poor or unattainable central access
9. Has bleeding disorder
10. Contraindications to systemic anticoagulation
11. Allergic to iodine, albumin, or iodinated I-131 albumin
12. Active myocarditis or hypertrophic obstructive cardiomyopathy
13. Severe uncorrected valvular stenosis
14. Complex congenital heart disease
15. Systemic infection
16. Previous organ transplant
17. Enrollment in other clinical trials
18. Life expectancy 6 months