A Feasibility Study on Ultrafiltration and Blood Volume Measurements

NCT04241718 | Terminated FDA Device

• 1 other identifier: CLIN06477
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Decompensated Heart Failure; Fluid Overload

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Single-arm

OTHER

No comparator, placebo, or randomization

Device: Aquadex FlexFlow System and BVA-100

Interventions

Aquadex FlexFlow System and BVA-100 DEVICE

Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Subject or legally authorized representative is able to provide appropriate consent to participate
• Hospitalized for ADHF with fluid overload as indicated by at least two of the following:
• Pitting edema ≥ 2+ of the lower extremities
• Jugular venous distention \> 8 cm
• Pulmonary edema/pleural effusion on chest x-ray
• Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
• Respiration rate ≥ 20 per minute

You may not qualify if:

• Unable or unwillingness to provide informed consent or to comply with study requirements
• Subject who is pregnant
• Acute coronary syndrome
• Known bilateral renal artery stenosis
• Serum creatinine \> 3.0 mg/dL at the time of presentation
• Subject receiving ongoing active treatment with diuretics (up to 2 doses of IV diuretics are permitted before initiation of ultrafiltration therapy)
• Systolic blood pressure ≤ 90 mmHg
• Poor or unattainable central access
• Has bleeding disorder
• Contraindications to systemic anticoagulation
• Allergic to iodine, albumin, or iodinated I-131 albumin
• Active myocarditis or hypertrophic obstructive cardiomyopathy
• Severe uncorrected valvular stenosis
• Complex congenital heart disease
• Systemic infection

Sponsors & Collaborators

• Nuwellis, Inc.: lead
• Daxor Corporation: collaborator

Study Sites (1)

Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Rosa Costanzo, MD

  Edward Hospital Center for Advanced Heart Failure

  PRINCIPAL INVESTIGATOR

• Maria Rosa Costanzo, MD

  Edward-Elmhurst Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: January 27, 2020
• Study Start: December 19, 2019
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)