Suspended

Early Aquapheresis for Decompensated Heart Failure in Outpatients

Study Aim

This study aims to compare the number of hospital readmissions due to heart failure and weight changes in outpatients receiving early Aquapheresis treatment versus a control group, over periods of 7, 30, 60, and 90 days post-treatment.

What is being tested

Aquapheresis

+ IV Diuretics

DeviceDrug

Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: June 2021

See protocol details

Summary

Principal SponsorRamona Gelzer Bell

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 8, 2021

Actual date on which the first participant was enrolled.

This clinical trial focuses on a condition called congestive heart failure (CHF), which affects nearly 2% of the U.S. population and is a leading cause of hospitalization for people over 65. The study aims to evaluate the effectiveness of a treatment called Aquapheresis in patients with decompensated heart failure who are treated as outpatients at a Veterans hospital. Decompensated heart failure is a state where the heart is unable to pump blood effectively, leading to fluid buildup in the body. Aquapheresis is a procedure that helps remove this excess fluid. The study is particularly important as many patients with decompensated heart failure are resistant to diuretics, a common treatment for this condition, and may require alternative methods like Aquapheresis to manage their symptoms and reduce hospital readmissions. During the study, participants will be divided into two groups: one receiving the standard treatment for decompensated heart failure, and the other receiving Aquapheresis in addition to the standard treatment. The primary outcomes measured will be the number of hospital readmissions due to heart failure within 7, 30, 60, and 90 days post-treatment. Additionally, changes in weight will be monitored during these same time periods as an indicator of fluid removal. The goal is to determine if Aquapheresis can lead to fewer hospital readmissions and better fluid management compared to the standard treatment alone.

Official TitleEfficacy of Aquapheresis in Patients Treated as Outpatients With Decompensated Heart Failure at a Veterans Hospital

NCT04572867

Principal SponsorRamona Gelzer Bell

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Failure

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. -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Per protocol, if randomized to Aquapheresis arm (AQ), all diuretics are discontinued and AQ will be administered as per established protocol. BMP and CBC will be checked prior to initiation and as needed, 7-10 days, 30, 60 and 90 days post discharge. Note, aquapheresis rate is to be decreased by 100 cc/hr if Hgb increases by 1gm/dL, and stopped if rate is decreased to 50 cc/hr or reaches euvolemia, whichever comes first.

Group II

Active Comparator

Per protocol (Fig 2), if randomized to IV diuretic therapy arm (IV), the patient will receive initial dose of IV diuretic based on base line renal function; then the dose will be doubled every 2 hrs if refractory, to a maximum of 8mg IV Bumex (or 320mg IV Lasix). Metolazone may be added at 2.5mg PO 30 minutes before loop diuretic if CR\< 2.0, or 5mg PO if Cr \> 2.0, if refractory to high dose loop diuretic. If a patient in IV arm is refractory to maximum 320 mg IV Lasix or 8 mg IV Bumex plus Metolazone then the patient may cross over to AQ arm.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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SuspendedNo study centers