Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-19 @ 11:39 PM
Study NCT ID:
NCT05240651
Status:
RECRUITING
Last Update Posted:
2025-05-16
First Post:
2022-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2022-02-13', 'studyFirstSubmitQcDate': '2022-02-13', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR)', 'timeFrame': 'Baseline, At Discharge (up to 1 week)', 'description': 'The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine SVI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in stroke volume index.'}], 'secondaryOutcomes': [{'measure': 'Change in Stroke Volume Index (SVI) before passive leg raise (PLR)', 'timeFrame': 'Baseline, At Discharge (up to 1 week)', 'description': 'The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine SVI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in stroke volume index.'}, {'measure': 'Change in Stroke Volume Index (SVI) after passive leg raise (PLR)', 'timeFrame': 'Baseline, At Discharge (up to 1 week)', 'description': 'The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine SVI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in stroke volume index.'}, {'measure': 'Change in estimated Cardiac Output (CO) before passive leg raise (PLR)', 'timeFrame': 'Baseline, At Discharge (up to 1 week)', 'description': 'The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CO. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in CO.'}, {'measure': 'Change in estimated Cardiac Output (CO) after passive leg raise (PLR)', 'timeFrame': 'Baseline, At Discharge (up to 1 week)', 'description': 'The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CO. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in CO.'}, {'measure': 'Change in estimated Cardiac Index (CI) before passive leg raise (PLR)', 'timeFrame': 'Baseline, At Discharge (up to 1 week)', 'description': 'The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in CI.'}, {'measure': 'Change in estimated Cardiac Index (CI) after passive leg raise (PLR)', 'timeFrame': 'Baseline, At Discharge (up to 1 week)', 'description': 'The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine CI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in CI.'}, {'measure': 'Change in heart rate before passive leg raise (PLR)', 'timeFrame': 'Baseline, At Discharge (up to 1 week)'}, {'measure': 'Change in heart rate after passive leg raise (PLR)', 'timeFrame': 'Baseline, At Discharge (up to 1 week)'}, {'measure': 'Change in Mean arterial pressure before passive leg raise (PLR)', 'timeFrame': 'Baseline, At Discharge (up to 1 week)'}, {'measure': 'Change in Mean arterial pressure after passive leg raise (PLR)', 'timeFrame': 'Baseline, At Discharge (up to 1 week)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Decompensated Heart Failure']}, 'descriptionModule': {'briefSummary': 'This is a prospective cohort study for 50 patients admitted to the cardiac care unit requiring clinically-indicated diuretic therapy for congestive heart failure. The purpose of this study is to assess the role of non-invasive cardiac output monitoring (NICOM) with the Starling Fluid Management System (Baxter Medical, Deerfield, IL) in determining volume status in patients with acute decompensated heart failure requiring intravenous diuretic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Adults age \\> 18\n* Decompensated heart failure requiring clinically-indicated intravenous (IV) diuresis\n* Admission to the cardiac care unit (CCU) or the step down unit (SDU)\n* Ability to perform a passive leg raise (PLR)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of congestive acute decompensated heart failure (preserved or reduced ejection fraction) requiring clinically indicated IV diuresis\n2. Admission to coronary/cardiac intensive care unit or cardiac step down unit\n3. Able to provide written informed consent\n4. Anticipated need for IV diuretics \\> 24 hrs\n\nExclusion Criteria:\n\n1. Prisoner, pregnancy or post-partum stage, or age \\< 18 years\n2. Known allergy to sensory material or gel\n3. End stage renal disease or need for CRRT\n4. Inability or contraindication to do a passive leg raise with both extremities (i.e., balloon pump, impella, spinal injury, amputation)\n5. Other situation that might increase subject risk, interfere with study procedures, or confound study findings based on the opinion of the clinician/investigator\n6. Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05240651', 'briefTitle': 'Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure', 'orgStudyIdInfo': {'id': '20-02048'}}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Carlos Alviar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stuart Katz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicholas Kiefer, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Carlos Alviar, MD', 'role': 'CONTACT', 'email': 'carlos.alviar@nyulangone.org', 'phone': '212-263-6635'}], 'overallOfficials': [{'name': 'Carlos Alviar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.', 'accessCriteria': 'The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to carlos.alviar@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}