Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-27 @ 6:24 AM
Study NCT ID:
NCT06278792
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2024-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'All physicians were blinded for the spot urinary sodium measurements. Additionally, while urine was collected for the first 48 h in both groups, the analysis was only performed afterwards.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The EASY-HF study was a single-centre, randomized, open-label study comparing standard of care (SOC) diuretic management at the treating physician's discretion with a nurse-led natriuresis-guided protocol in patients with ADHF."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-02-19', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diuretic dose', 'timeFrame': '48 hours', 'description': 'Dose of loop diuretics and other diuretic agents administered'}, {'measure': 'User-friendliness device and protocol', 'timeFrame': '180 days', 'description': 'Questionnaire for the nursing staff with regard to user-friendliness of device and diuretic protocol (1 (totally disagree) to 10 (completely agree))'}, {'measure': 'Weight', 'timeFrame': '48 hours', 'description': 'Body weight change'}, {'measure': 'Number of participants with need for heart failure rehospitalization', 'timeFrame': '180 days', 'description': 'Heart failure rehospitalization during the first 180 after start of the study'}, {'measure': 'Rate of all-cause mortality', 'timeFrame': '180 days', 'description': 'All-cause mortality during the first 180 after start of the study'}, {'measure': 'Length of hospital stay', 'timeFrame': '180 days', 'description': 'The time frame between hospital admission and discharge will be calculated'}, {'measure': 'Number of participants with severe hypotension', 'timeFrame': '48 hours', 'description': 'systolic blood pressure below 85mmHg'}, {'measure': 'Number of participants with abnormal blood parameters', 'timeFrame': '3-day follow-up', 'description': 'Any abnormal laboratory parameters in the blood (electrolytes, renal function) during a 3 day follow-up will be reported'}], 'primaryOutcomes': [{'measure': 'Urinary sodium excretion after 48 hours', 'timeFrame': '48 hours', 'description': 'Total natriuresis after 48 hours (mmol)'}], 'secondaryOutcomes': [{'measure': 'Urinary output after 48 hours', 'timeFrame': '48 hours', 'description': 'Total diuresis after 48 hours (ml)'}, {'measure': 'Urinary sodium excretion on daily base', 'timeFrame': '24 hours', 'description': 'Total natriuresis (mmol) during the first and second 24 h'}, {'measure': 'Urinary output on daily base', 'timeFrame': '24 hours', 'description': 'Total diuresis during the first and second 24 h'}, {'measure': 'Achievement of decongestion', 'timeFrame': '48 hours', 'description': 'Congestion score of no more than trace edema (score \\< 2) after 48 hours of diuretic treatment. Minimum score 0 (decongested), maximum score 10 (severe congested)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute decompensated heart failure', 'natriuresis', 'nurse-led', 'diuretic therapy'], 'conditions': ['Acute Decompensated Heart Failure']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are:\n\n* difference in natriuresis and diuresis\n* feasibility of the protocol.\n\nParticipants will be asked to gather two 24 h urine collections.\n\nResearchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours.', 'detailedDescription': "The EASY-HF study was a single-centre, randomized, open-label study comparing standard of care (SOC) diuretic management at the treating physician's discretion with a nurse-led natriuresis-guided protocol in patients with ADHF. A bedside sensor was used to measure the urinary sodium content.The primary endpoint was total natriuresis after 48 hours. Secondary endpoints included safety profile and user-friendliness of both the protocol and the point-of-care sensor."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years\n* Provide written informed consent\n* Hospital admission with signs and symptoms of congestion warranting intravenous decongestive therapy\n* Congestion score of at least 2 based upon the presence of edema, pleural effusion, or ascites\n* N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of at least 500 ng per litre (800 ng per litre in case of atrial fibrillation)\n\nExclusion Criteria:\n\n* Patients unable to collect a 48h-urine collection\n* Estimated GFR below 20 ml/min/1.73m\\^2\n* Concomitant diagnosis of an acute coronary syndrome\n* Need for inotropic or vasopressor support\n* Ventricular assist device\n* Renal replacement therapy\n* Treatment with intravenous loop diuretics \\> 80mg furosemide or an equivalence of another loop diuretic (40mg furosemide = 1mg bumetanide) during the index hospitalization and prior to randomization'}, 'identificationModule': {'nctId': 'NCT06278792', 'acronym': 'EASY-HF', 'briefTitle': 'Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Ziekenhuis Oost-Limburg'}, 'officialTitle': 'Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': 'Z-2021104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': "48 hour diuretic management at the treating physician's discretion", 'interventionNames': ['Procedure: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '48-hour nurse-led natriuresis-guided protocol', 'interventionNames': ['Procedure: Diuretic protocol']}], 'interventions': [{'name': 'Diuretic protocol', 'type': 'PROCEDURE', 'description': 'Nurse-led natriuresis-guided protocol based on a bedside urinary sodium result', 'armGroupLabels': ['Intervention']}, {'name': 'Standard of Care', 'type': 'PROCEDURE', 'description': 'Diuretic therapy at the discretion of the physician', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg AV', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}], 'overallOfficials': [{'name': 'Wilfried Mullens, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziekenhuis Oost-Limburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fund for Scientific Research, Flanders, Belgium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}