Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT04241718
Status:
TERMINATED
Last Update Posted:
2024-11-14
First Post:
2019-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Feasibility Study on Ultrafiltration and Blood Volume Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2019-11-25', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Evaluate changes in blood volume as measured by BVA from before initiation until completion of extracorporeal fluid removal by ultrafiltration', 'timeFrame': 'Through study procedure completion, average of 2 weeks', '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.'}, {'measure': '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', 'timeFrame': 'Through study procedure completion, average of 2 weeks', '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.'}, {'measure': '3. Evaluate the temporal relationship between changes in blood volume, as measured by BVA , and changes in clinical signs and symptoms of fluid overload', 'timeFrame': 'Through study procedure completion, average of 2 weeks', '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.'}, {'measure': '4. Evaluate the temporal relationship between changes in HCT, as measured by Aquadex HCT, and changes in clinical signs and symptoms of fluid overload', 'timeFrame': 'Through study procedure completion, average of 2 weeks', '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.'}, {'measure': '5. Total net fluid loss prior to hospital discharge', 'timeFrame': 'Daily during study procedure, average of 2 weeks', 'description': 'The total net fluid removed during the ultrafiltration therapy will be evaluated.'}, {'measure': '6. Change in urinary sodium concentration from baseline to ultrafiltration completion', 'timeFrame': 'Through study procedure completion, average of 2 weeks', 'description': 'Urinary sodium concentration profile from baseline to ultrafiltration completion will be evaluated.'}, {'measure': '7. Change in biomarkers from baseline until discharge:', 'timeFrame': 'through study completion, average of 2 weeks', 'description': '* Comprehensive Metabolic Panel (CMP)/Basic Metabolic Panel (BMP)\n* N-terminal proB- type natriuretic peptide (NT-proBNP)\n* Troponin-I\n* Urine Nephrocheck'}, {'measure': '8. Adverse events of special interest', 'timeFrame': 'through study completion, average of 1 year', 'description': '* Acute coronary syndrome\n* Bleeding (requiring blood transfusion or drop of hemoglobin \\>3g/dl)\n* Catheter-related bloodstream infections\n* Hypotension necessitating intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acute Decompensated Heart Failure', 'Fluid Overload']}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': '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.\n\nBVA-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older\n2. Subject or legally authorized representative is able to provide appropriate consent to participate\n3. Hospitalized for ADHF with fluid overload as indicated by at least two of the following:\n\n 1. Pitting edema ≥ 2+ of the lower extremities\n 2. Jugular venous distention \\> 8 cm\n 3. Pulmonary edema/pleural effusion on chest x-ray\n 4. Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea\n 5. Respiration rate ≥ 20 per minute\n\nExclusion Criteria:\n\n1. Unable or unwillingness to provide informed consent or to comply with study requirements\n2. Subject who is pregnant\n3. Acute coronary syndrome\n4. Known bilateral renal artery stenosis\n5. Serum creatinine \\> 3.0 mg/dL at the time of presentation\n6. Subject receiving ongoing active treatment with diuretics (up to 2 doses of IV diuretics are permitted before initiation of ultrafiltration therapy)\n7. Systolic blood pressure ≤ 90 mmHg\n8. Poor or unattainable central access\n9. Has bleeding disorder\n10. Contraindications to systemic anticoagulation\n11. Allergic to iodine, albumin, or iodinated I-131 albumin\n12. Active myocarditis or hypertrophic obstructive cardiomyopathy\n13. Severe uncorrected valvular stenosis\n14. Complex congenital heart disease\n15. Systemic infection\n16. Previous organ transplant\n17. Enrollment in other clinical trials\n18. Life expectancy ≤ 6 months'}, 'identificationModule': {'nctId': 'NCT04241718', 'briefTitle': 'A Feasibility Study on Ultrafiltration and Blood Volume Measurements', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nuwellis, Inc.'}, 'officialTitle': 'A Feasibility Study on Ultrafiltration and Blood Volume Measurements', 'orgStudyIdInfo': {'id': 'CLIN06477'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single-arm', 'description': 'No comparator, placebo, or randomization', 'interventionNames': ['Device: Aquadex FlexFlow System and BVA-100']}], 'interventions': [{'name': 'Aquadex FlexFlow System and BVA-100', 'type': 'DEVICE', 'description': 'Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100', 'armGroupLabels': ['Single-arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60540', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Cardiovascular Institute', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}], 'overallOfficials': [{'name': 'Maria Rosa Costanzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edward Hospital Center for Advanced Heart Failure'}, {'name': 'Maria Rosa Costanzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edward-Elmhurst Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nuwellis, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Daxor Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}