Overview

Aquapheresis Efficacy in Outpatients With Decompensated Heart Failure

Status:
Withdrawn
Trial end date:
2021-07-27
Target enrollment:
0
Participant gender:
All
Summary
With this research the Investigators hope to learn if early aquapheresis in an outpatient setting will improve congestive heart failure symptoms in outpatients with decompensated heart failure who have been refractory to high dose diuretics. In previous trials in inpatient settings, aquapheresis has been demonstrated to improve quality of life and reduce hospital visits for those who have undergone the treatment. This study is one of the first to evaluate the effectiveness of aquapheresis in veterans with congestive heart failure in an outpatient setting. The aquapheresis device, Aquadex FlexFlow® System, manufactured by CHF Solutions™, Minneapolis, MN, has been approved by the Food and Drug Administration (FDA) for removing excess sodium and fluid from patients suffering from volume overload, like in congestive heart failure.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ramona Gelzer Bell
Treatments:
Diuretics
Criteria
Inclusion Criteria:

Subjects must be 18 years of age or older already on standard of care therapy including
Angiotensin Converting Enzyme Inhibitors (ACE-I), Angiotensin

Receptor Blockers (ARBs), Sacubitril/Valsartan, beta-blocker, oral diuretic (80 mg Lasix/2
mg Bumex/40 mg Torsemide+/-Thiazide diuretic), and meet the following inclusion criteria to
be enrolled:

Inclusion Criteria:

1. CHF refractory to oral diuretic (80mg Lasix, 2mg Bumex, or 40mg Torsemide)

2. Volume overload secondary to systolic or diastolic HF, evidenced by at least 2 of the
following:

1. Elevated BNP (>100)

2. Paroxysmal nocturnal dyspnea or orthopnea

3. Elevated jugular venous distention (>/ 7 cm)

4. X-ray findings consisted with CHF

5. Presence of ascites or LE edema . -

Exclusion Criteria:

1. Acute Coronary Syndrome

2. Hypertensive urgency or emergency

3. Rapid atrial fibrillation difficult to control

4. Contraindication to anticoagulation

5. Pregnancy

6. Requires hemodialysis (> CR > 3.0 mg/dl)

7. Symptomatic hypotension

8. Poor venous access

9. Pressor dependent. -