Acute Decompensated Heart FailureNCT04241718
A Feasibility Study on Ultrafiltration and Blood Volume Measurements
A study testing Aquadex FlexFlow System and BVA-100 in people with Acute Decompensated Heart Failure and Fluid Overload, run by Nuwellis, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure, Fluid Overload
- What is being tested?
- Aquadex FlexFlow System and BVA-100
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 27 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwest Cardiovascular Institute
Naperville, Illinois, 60540
About this study
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).
Read the 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.
- Conditions
- Acute Decompensated Heart Failure, Fluid Overload
- Being tested
- Aquadex FlexFlow System and BVA-100
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquadex FlexFlow System and BVA-100Device
Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Other | No comparator, placebo, or randomization Receives: Device: Aquadex FlexFlow System and BVA-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: through study completion, average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start19 Dec 2019
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuwellis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daxor Corporation
- Responsible party
- Sponsor
- Investigators
- Maria Rosa Costanzo, MD, Principal investigator, Edward Hospital Center for Advanced Heart FailureMaria Rosa Costanzo, MD, Principal investigator, Edward-Elmhurst Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241718
- Sponsor's protocol ID
- CLIN06477
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2019
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on Ultrafiltration and Blood Volume Measurements
- ClinicalTrials.gov ID
- NCT04241718
- Acronym / sponsor ID
- CLIN06477
- Conditions
- Acute Decompensated Heart Failure, Fluid Overload
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nuwellis, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Daxor Corporation
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Other | Device: Aquadex FlexFlow System and BVA-100No comparator, placebo, or randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquadex FlexFlow System and BVA-100Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100 | Device | Single-arm |
Primary outcome
1. Evaluate changes in blood volume as measured by BVA from before initiation until completion of extracorporeal fluid removal by ultrafiltration
Time frame: Through study procedure completion, average of 2 weeks
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
Time frame: Through study procedure completion, average of 2 weeks
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
Time frame: Through study procedure completion, average of 2 weeks
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
Time frame: Through study procedure completion, average of 2 weeks
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
Time frame: Daily during study procedure, average of 2 weeks
The total net fluid removed during the ultrafiltration therapy will be evaluated.
6. Change in urinary sodium concentration from baseline to ultrafiltration completion
Time frame: Through study procedure completion, average of 2 weeks
Urinary sodium concentration profile from baseline to ultrafiltration completion will be evaluated.
7. Change in biomarkers from baseline until discharge:
Time frame: through study completion, average of 2 weeks
* 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
Time frame: through study completion, average of 1 year
* Acute coronary syndrome * Bleeding (requiring blood transfusion or drop of hemoglobin >3g/dl) * Catheter-related bloodstream infections * Hypotension necessitating intervention
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Rosa Costanzo, MD principal investigator
Edward Hospital Center for Advanced Heart Failure
Maria Rosa Costanzo, MD principal investigator
Edward-Elmhurst Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquadex FlexFlow System and BVA-100 in people with Acute Decompensated Heart Failure and Fluid Overload, run by Nuwellis, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Evaluate changes in blood volume as measured by BVA from before initiation until completion of extracorporeal fluid removal by ultrafiltration (time frame: Through study procedure completion, average of 2 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.