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A Feasibility Study on Ultrafiltration and Blood Volume Measurements

Primary Purpose

Acute Decompensated Heart Failure, Fluid Overload

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aquadex FlexFlow System and BVA-100

About this trial

This is an interventional diagnostic trial for Acute Decompensated Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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:

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
Previous organ transplant
Enrollment in other clinical trials
Life expectancy ≤ 6 months

Sites / Locations

Midwest Cardiovascular Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-arm

Arm Description

No comparator, placebo, or randomization

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

5. Total net fluid loss prior to hospital discharge

The total net fluid removed during the ultrafiltration therapy will be evaluated.

6. Change in urinary sodium concentration from baseline to ultrafiltration completion

Urinary sodium concentration profile from baseline to ultrafiltration completion will be evaluated.

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04241718

First Posted

November 25, 2019

Last Updated

February 2, 2023

Sponsor

Nuwellis, Inc.

Collaborators

Daxor Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04241718

Brief Title

A Feasibility Study on Ultrafiltration and Blood Volume Measurements

Official Title

A Feasibility Study on Ultrafiltration and Blood Volume Measurements

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Terminated

Why Stopped

Slow enrollment

Study Start Date

December 19, 2019 (Actual)

Primary Completion Date

December 27, 2022 (Actual)

Study Completion Date

December 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nuwellis, Inc.

Collaborators

Daxor Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Decompensated Heart Failure, Fluid Overload

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single-arm

Arm Type

Other

Arm Description

No comparator, placebo, or randomization

Intervention Type

Device

Intervention Name(s)

Aquadex FlexFlow System and BVA-100

Intervention Description

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

Primary Outcome Measure Information:

Title

1. Evaluate changes in blood volume as measured by BVA from before initiation until completion of extracorporeal fluid removal by ultrafiltration

Description

BVA will be used to evaluate changes in blood volume from baseline (i.e., before initiation) until completion of extracorporeal fluid removal by ultrafiltration.

Time Frame

Through study procedure completion, average of 2 weeks

Title

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

Description

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.

Time Frame

Through study procedure completion, average of 2 weeks

Title

3. Evaluate the temporal relationship between changes in blood volume, as measured by BVA , and changes in clinical signs and symptoms of fluid overload

Description

Temporal relationship between blood volume change (as measured by the BVA) and changes in clinical signs and symptoms of fluid overload will be evaluated.

Time Frame

Through study procedure completion, average of 2 weeks

Title

4. Evaluate the temporal relationship between changes in HCT, as measured by Aquadex HCT, and changes in clinical signs and symptoms of fluid overload

Description

Temporal relationship between HCT change (as measured by Aquadex HCT sensor) and changes in clinical signs and symptoms of fluid overload will be evaluated.

Time Frame

Through study procedure completion, average of 2 weeks

Title

5. Total net fluid loss prior to hospital discharge

Description

The total net fluid removed during the ultrafiltration therapy will be evaluated.

Time Frame

Daily during study procedure, average of 2 weeks

Title

6. Change in urinary sodium concentration from baseline to ultrafiltration completion

Description

Urinary sodium concentration profile from baseline to ultrafiltration completion will be evaluated.

Time Frame

Through study procedure completion, average of 2 weeks

Title

7. Change in biomarkers from baseline until discharge:

Description

Comprehensive Metabolic Panel (CMP)/Basic Metabolic Panel (BMP) N-terminal proB- type natriuretic peptide (NT-proBNP) Troponin-I Urine Nephrocheck

Time Frame

through study completion, average of 2 weeks

Title

8. Adverse events of special interest

Description

Acute coronary syndrome Bleeding (requiring blood transfusion or drop of hemoglobin >3g/dl) Catheter-related bloodstream infections Hypotension necessitating intervention

Time Frame

through study completion, average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Previous organ transplant Enrollment in other clinical trials Life expectancy ≤ 6 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Rosa Costanzo, MD

Organizational Affiliation

Edward Hospital Center for Advanced Heart Failure

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maria Rosa Costanzo, MD

Organizational Affiliation

Edward-Elmhurst Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Midwest Cardiovascular Institute

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60540

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Feasibility Study on Ultrafiltration and Blood Volume Measurements

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