Aquapheresis Efficacy in Outpatients With Decompensated Heart Failure

NCT04572867 | Withdrawn FDA Device

• 1 other identifier: AQUA
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Heart Failure; Congestive Heart Failure; Decompensated Heart Failure

Keywords

Aquapheresis; Diuresis

Outcome Measures

Primary Outcomes (8)

• Number of Hospitalizations by 7 days post-treatment

  Compare number of hospitalization readmissions for CHF between Intervention (Aquaphersis arm) \& Control groups

  Between outpatient treatment and 7-days after outpatient treatment

• Number of Hospitalizations by 30 days post-treatment

  Compare number of hospitalization readmissions for CHF between Intervention (Aquaphersis arm) \& Control groups

  Between outpatient treatment and 30 days after outpatient treatment

• Number of Hospitalizations by 60 days post-treatment

  Compare number of hospitalization readmissions for CHF between Intervention (Aquaphersis arm) \& Control groups

  Between outpatient treatment and 60 days after outpatient treatment

• Number of Hospitalizations by 90 days post-treatment

  Compare number of hospitalization readmissions for CHF between Intervention (Aquaphersis arm) \& Control groups

  Between outpatient treatment and 90 days after outpatient treatment

• Weight change by 7 days post-treatment

  Compare weight change (pounds) in patients between Intervention \& Control groups

  Outpatient treatment to 7 days after outpatient treatment

• Weight change by 30 days post-treatment

  Compare weight change (pounds) in patients between Intervention \& Control groups

  Outpatient treatment to 30 days after outpatient treatment

• Weight change by 60 days post-treatment

  Compare weight change (pounds) in patients between Intervention \& Control groups

  Outpatient treatment to 60 days after outpatient treatment

• Weight change by 90 days post-treatment

  Compare weight change (pounds) in patients between Intervention \& Control groups

  Outpatient treatment to 90 days after outpatient treatment

Secondary Outcomes (39)

• Total fluid removal

  Baseline (Randomization) to outpatient discharge

• Blood urea nitrogen at Baseline

  Baseline (Randomization)

• Blood urea nitrogen at 7 days post-treatment

  7 days after outpatient treatment

• Blood urea nitrogen at 30 days post-treatment

  30 days after outpatient treatment

• Blood urea nitrogen at 60 days post-treatment

  60 days after outpatient treatment

Study Arms (2)

Aquapheresis

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.

Device: Aquapheresis

IV Diuretics

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.

Drug: IV Diuretics

Interventions

Aquapheresis DEVICE

The Aquadex FlexFlow® Fluid Removal System (from CHF Solutions™, Minneapolis, MN) is an FDA approved device that provides mechanical isosmotic fluid removal in volume-overloaded CHF patients via veno-venous ultrafiltration, and has been used in patients with congestive heart failure refractory to diuretics, it should be considered standard of care also. This study is using it in a randomized, controlled study in the Outpatient setting. The Aquadex FlexFlow® Fluid Removal System is a dual rotary pump device used with a sterile, single-use UF 500 Blood Circuit Set. Blood withdrawal is usually from a peripheral arm vein (such as the antecubital vein), using a 16 or 18- gauge, 3.5 cm catheter (similar to a standard IV catheter). A similar IV catheter is used for blood return via a second peripheral vein (typically in the forearm).

Also known as: Ultrafiltration, Hemodialysis

Aquapheresis

IV Diuretics DRUG

Active Comparator: Intravenous Diuretics 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 the patient in IV arm is refractory to max 320 mg IV Lasix or 8 mg IV Bumex plus Metolazone then the patient may cross over to AQ arm.

Also known as: Intravenous Diuretics

IV Diuretics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be 18 years of age or older already on standard of care therapy including Angiotensin Converting Enzyme Inhibitors (ACE-I), Angiotensin
• CHF refractory to oral diuretic (80mg Lasix, 2mg Bumex, or 40mg Torsemide)
• Volume overload secondary to systolic or diastolic HF, evidenced by at least 2 of the following:
• Elevated BNP (\>100)
• Paroxysmal nocturnal dyspnea or orthopnea
• Elevated jugular venous distention (\>/ 7 cm)
• X-ray findings consisted with CHF
• Presence of ascites or LE edema . -

You may not qualify if:

• Acute Coronary Syndrome
• Hypertensive urgency or emergency
• Rapid atrial fibrillation difficult to control
• Contraindication to anticoagulation
• Pregnancy
• Requires hemodialysis (\> CR \> 3.0 mg/dl)
• Symptomatic hypotension
• Poor venous access
• Pressor dependent. -

Sponsors & Collaborators

• Ramona Gelzer Bell: lead

Related Publications (23)

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• Krumholz HM, Chen YT, Wang Y, Vaccarino V, Radford MJ, Horwitz RI. Predictors of readmission among elderly survivors of admission with heart failure. Am Heart J. 2000 Jan;139(1 Pt 1):72-7. doi: 10.1016/s0002-8703(00)90311-9.

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  PMID: 15846257 BACKGROUND

• Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Am J Cardiol. 1999 Jan 21;83(2A):1A-38A. No abstract available.

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  BACKGROUND

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  PMID: 11583865 BACKGROUND

• Rimondini A, Cipolla CM, Della Bella P, Grazi S, Sisillo E, Susini G, Guazzi MD. Hemofiltration as short-term treatment for refractory congestive heart failure. Am J Med. 1987 Jul;83(1):43-8. doi: 10.1016/0002-9343(87)90495-5.

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• Jaski BE, Ha J, Denys BG, Lamba S, Trupp RJ, Abraham WT. Peripherally inserted veno-venous ultrafiltration for rapid treatment of volume overloaded patients. J Card Fail. 2003 Jun;9(3):227-31. doi: 10.1054/jcaf.2003.28.

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  PMID: 8154506 BACKGROUND

• Liang KV, Hiniker AR, Williams AW, Karon BL, Greene EL, Redfield MM. Use of a novel ultrafiltration device as a treatment strategy for diuretic resistant, refractory heart failure: initial clinical experience in a single center. J Card Fail. 2006 Dec;12(9):707-14. doi: 10.1016/j.cardfail.2006.08.210.

  PMID: 17174232 BACKGROUND

• Kwok CS, Wong CW, Rushton CA, Ahmed F, Cunnington C, Davies SJ, Patwala A, Mamas MA, Satchithananda D. Ultrafiltration for acute decompensated cardiac failure: A systematic review and meta-analysis. Int J Cardiol. 2017 Feb 1;228:122-128. doi: 10.1016/j.ijcard.2016.11.136. Epub 2016 Nov 9.

  PMID: 27863352 BACKGROUND

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.

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MeSH Terms

Conditions

Heart Failure

Interventions

Ultrafiltration; Renal Dialysis; Diuretics

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena; Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ramona Gelzer Bell, MD

  James A. Haley Veterans Administration Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Congestive Heart Failure Program

Model Details: This is a Controlled Trial with two arms (aquapheresis and IV diuretics/Control), but there is the potential for cross-over to aquapheresis if a patient receiving diuretics is refractory to maximum doses of IV diuretics.

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: October 1, 2020
• Study Start: June 8, 2021
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share