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A Feasibility Study on Ultrafiltration and Blood Volume Measurements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241718
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Daxor Corporation
Information provided by (Responsible Party):
CHF Solutions

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

Condition or disease Intervention/treatment Phase
Acute Decompensated Heart Failure Fluid Overload Device: Aquadex FlexFlow System and BVA-100 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Feasibility Study on Ultrafiltration and Blood Volume Measurements
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 5. Total net fluid loss prior to hospital discharge [ Time Frame: Daily during study procedure, average of 2 weeks ]
  6. 6. Change in urinary sodium concentration from baseline to ultrafiltration completion [ Time Frame: Through study procedure completion, average of 2 weeks ]
  7. 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. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241718


Contacts
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Contact: Audrey Singh 952-345-4217 audrey.singh@chf-solutions.com

Locations
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United States, Illinois
Edward Hospital Center for Advanced Heart Failure Recruiting
Naperville, Illinois, United States, 60566
Contact: Stan Skaluba, MD    630-932-2165      
Contact: Maria Rosa Costanzo, MD    630-932-2165      
Principal Investigator: Stan Skaluba, MD         
Sub-Investigator: Maria Rosa Costanzo, MD         
Sponsors and Collaborators
CHF Solutions
Daxor Corporation
Investigators
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Principal Investigator: Maria Rosa Costanzo, MD Edward Hospital Center for Advanced Heart Failure
Principal Investigator: Maria Rosa Costanzo, MD Edward-Elmhurst Health System
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Responsible Party: CHF Solutions
ClinicalTrials.gov Identifier: NCT04241718    
Other Study ID Numbers: CLIN06477
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan undecided

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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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases