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

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the research is to determine if patients have fewer Heart Failure (HF) events after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90 days of discharge from the hospital. Heart Failure events are defined as returning to the hospital, clinic or emergency department (ED) for treatment of HF symptoms.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gambro Renal Products, Inc.; Nuwellis, Inc.
• Collaborator: Gambro UF Solutions, Inc.
• Treatments: Diuretics; Furosemide; Sodium Potassium Chloride Symporter Inhibitors

Criteria

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