A Feasibility Study on Ultrafiltration and Blood Volume Measurements

The objective of this feasibility study is to characterize the performance of the Aquadex FlexFlow® System with the hematocrit (HCT) feature in conjunction with Daxor's blood volume analyzer (BVA-100). The study will monitor blood volume changes during ultrafiltration (UF) therapy as a potential means to guide the removal of fluid in subjects hospitalized with acute decompensated heart failure (ADHF).

Study Overview

• Status: Terminated
• Conditions: Acute Decompensated Heart Failure; Fluid Overload
• Intervention / Treatment: Device: Aquadex FlexFlow System and BVA-100

Detailed Description

The study will measure blood volumes at various time intervals using the BVA-100 for comparison to corresponding readings of hematocrit (HCT) levels from the Aquadex FlexFlow HCT sensor. Establishing a correlation between BVA measurements (off-line measurements) and HCT sensor measurements (on-line measurements) may enable the use of the BVA-100 to guide ultrafiltration therapy by the Aquadex system for fluid removal.

BVA-100 measurements would be used at baseline to accurately determine patient suitability for fluid removal and while HCT measurements would be used to monitor blood volume changes during ultrafiltration therapy, potentially guiding the removal of fluid in subjects hospitalized with ADHF.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Cease; Phone Number: 952-345-4217; Email: megan.cease@nuwellis.com

Study Locations

• United States
  • Illinois
    • Naperville, Illinois, United States, 60540
      • Midwest Cardiovascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 years or older
2. Subject or legally authorized representative is able to provide appropriate consent to participate

3. Hospitalized for ADHF with fluid overload as indicated by at least two of the following:

   1. Pitting edema ≥ 2+ of the lower extremities
   2. Jugular venous distention > 8 cm
   3. Pulmonary edema/pleural effusion on chest x-ray
   4. Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
   5. Respiration rate ≥ 20 per minute

Exclusion Criteria:

1. Unable or unwillingness to provide informed consent or to comply with study requirements
2. Subject who is pregnant
3. Acute coronary syndrome
4. Known bilateral renal artery stenosis
5. Serum creatinine > 3.0 mg/dL at the time of presentation
6. Subject receiving ongoing active treatment with diuretics (up to 2 doses of IV diuretics are permitted before initiation of ultrafiltration therapy)
7. Systolic blood pressure ≤ 90 mmHg
8. Poor or unattainable central access
9. Has bleeding disorder
10. Contraindications to systemic anticoagulation
11. Allergic to iodine, albumin, or iodinated I-131 albumin
12. Active myocarditis or hypertrophic obstructive cardiomyopathy
13. Severe uncorrected valvular stenosis
14. Complex congenital heart disease
15. Systemic infection
16. Previous organ transplant
17. Enrollment in other clinical trials
18. Life expectancy ≤ 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Single-arm; No comparator, placebo, or randomization	Device: Aquadex FlexFlow System and BVA-100; Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Evaluate changes in blood volume as measured by BVA from before initiation until completion of extracorporeal fluid removal by ultrafiltration	BVA will be used to evaluate changes in blood volume from baseline (i.e., before initiation) until completion of extracorporeal fluid removal by ultrafiltration.	Through study procedure completion, average of 2 weeks
2. Evaluate if changes in blood volume, as measured by BVA, correlate with changes in HCT as measured by the device embedded in the Aquadex FlexFlow System ultrafiltration device	A correlation between BVA measured change in blood volume to changes in hematocrit (HCT) as measured by the online HCT sensor embedded in the Aquadex Flexflow system will be determined.	Through study procedure completion, average of 2 weeks
3. Evaluate the temporal relationship between changes in blood volume, as measured by BVA , and changes in clinical signs and symptoms of fluid overload	Temporal relationship between blood volume change (as measured by the BVA) and changes in clinical signs and symptoms of fluid overload will be evaluated.	Through study procedure completion, average of 2 weeks
4. Evaluate the temporal relationship between changes in HCT, as measured by Aquadex HCT, and changes in clinical signs and symptoms of fluid overload	Temporal relationship between HCT change (as measured by Aquadex HCT sensor) and changes in clinical signs and symptoms of fluid overload will be evaluated.	Through study procedure completion, average of 2 weeks
5. Total net fluid loss prior to hospital discharge	The total net fluid removed during the ultrafiltration therapy will be evaluated.	Daily during study procedure, average of 2 weeks
6. Change in urinary sodium concentration from baseline to ultrafiltration completion	Urinary sodium concentration profile from baseline to ultrafiltration completion will be evaluated.	Through study procedure completion, average of 2 weeks
7. Change in biomarkers from baseline until discharge:	Comprehensive Metabolic Panel (CMP)/Basic Metabolic Panel (BMP); N-terminal proB- type natriuretic peptide (NT-proBNP); Troponin-I; Urine Nephrocheck	through study completion, average of 2 weeks
8. Adverse events of special interest	Acute coronary syndrome; Bleeding (requiring blood transfusion or drop of hemoglobin >3g/dl); Catheter-related bloodstream infections; Hypotension necessitating intervention	through study completion, average of 1 year

Collaborators and Investigators

• Sponsor: Nuwellis, Inc.
• Collaborators: Daxor Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 19, 2019
• Primary Completion (ACTUAL): December 27, 2022
• Study Completion (ACTUAL): December 27, 2022

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CLIN06477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No