Study of Heart Failure Hospitalizations After Aquapheresis Therapy Compared to Intravenous (IV) Diuretic Treatment

The aim of the proposed AVOID-HF study is to confirm and expand the findings that fluid
removal by AQ reduces HF rehospitalizations at 90 days as well as the length of these HF
rehospitalizations. In the "Ultrafiltration Versus Intravenous Diuretics for Patients
Hospitalized for Acute Decompensated Heart Failure" (UNLOAD) study, the 90 day HF
re-hospitalizations were pre-specified secondary end-points. AVOID-HF is designed with a
primary end-point to determine if AQ reduces the number of HF events (Rehospitalization or
unscheduled outpatient or emergency room treatment for HF) after discharge from index
hospitalization compared to IV loop diuretics. AVOID will also explore days alive and out of
the hospital as a secondary end-point, which was not done in UNLOAD. In other words, the
AVOID-HF study is going beyond studying only the amount of fluid removal and will explore
whether the modality of fluid removal influences HF outcomes.

Inclusion Criteria:

1. 18 years of age or older

2. Male or non-pregnant female patients

3. Admitted to the hospital with a primary diagnosis of acute decompensated heart
failure (ADHF)

4. On regularly scheduled oral loop diuretics prior to admission

5. Fluid overload manifested by at least two of the following:

1. Pitting edema (2+) of the lower extremities

2. Jugular venous distention > 8 cm

3. Pulmonary edema or pleural effusion on chest x-ray

4. Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea

5. Respiration rate ≥ 20 per minute.

6. Have received ≤ 2 IV loop diuretics doses before randomization

7. Must be able to be enrolled into the trial ≤ 24 hours of their admission to the
hospital.

8. Provide written informed consent form as required by the local IRB (Institutional
Review Board)

Exclusion Criteria:

1. Acute coronary syndromes

2. Renal insufficiency with a sCr ≥ 3.0 mg/dl or planned renal replacement therapies

3. Systolic blood pressure < 90 mmHg at time of enrollment

4. Pulmonary Arterial Hypertension not secondary to left heart disease

5. Contraindications to systemic anticoagulation

6. Hematocrit > 45%

7. Inability to obtain venous access

8. Hemodynamic instability severe enough to require IV positive inotropic agents, IV
vasodilators or both

9. Use of iodinated radiocontrast material within the previous 72 hours or planned study
requiring IV contrast during the current hospitalization

10. Severe concomitant disease expected to prolong hospitalization

11. Severe concomitant disease expected to cause death in ≤ 90 days

12. Sepsis or ongoing systemic infection

13. Severe uncorrected valvular stenosis

14. Active myocarditis

15. Hypertrophic obstructive cardiomyopathy

16. Constrictive pericarditis or restrictive cardiomyopathy

17. Liver cirrhosis

18. Previous solid organ transplant

19. Requirement for mechanical ventilatory support

20. Presence of a mechanical circulatory support device

21. Unwillingness or inability to complete follow up

22. Active drug or ETOH substance abuse

23. Participating in another interventional clinical trial