Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT06397404
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2024-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VExUS in Patients With Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059347', 'term': 'Cardio-Renal Syndrome'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2024-04-06', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of acute kidney injury (AKI)', 'timeFrame': 'During 7 days of hospital stay', 'description': "Assessment of patient's serum creatinine at admission, in 48 hours, at day 7, and calculation of the amount of urine output in the first 6 h after the administration of a loop diuretic."}], 'secondaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': "During patient's hospital stay (up to 14 days)", 'description': 'Death from any cause, whichever came first'}, {'measure': 'Change in spot urine sodium content <50 mmol/l', 'timeFrame': "1 hour after first standard intravenous loop diuretic administration after patient's admission.", 'description': 'Sodium concentration in a spot urine sample is assessed in 1 hour after first intravenous loop diuretic administration. Reduction of natriuretic response in the face of congestion with volume overload with spot urine sodium content \\<50 mEq/L generally identifies a patient with an insufficient diuretic response.'}, {'measure': 'Development of diuretics resistance (defined as the need to double initial dose of intravenous furosemide in 6 hours without adding a different class of diuretic agents)', 'timeFrame': '6 hours after first intravenous furosemide administration', 'description': "Assessment of diuretic response: patient's urine output (ml/kg/hour) in the first 6 hours and patient's medical record with doses of administered diuretics."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiorenal Syndrome', 'Acute Kidney Injury', 'Fluid Overload', 'VEXUS', 'Natriuresis', 'Diuretics resistance', 'Congestion', 'Intrarenal blood flow'], 'conditions': ['Acute Heart Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.acc.org/-/media/Non-Clinical/Files-PDFs-Excel-MS-Word-etc/Meetings/2023/Agendas/ME-2023-Agenda.pdf', 'label': 'ACC Middle East \\& Eastern Mediterranean 2023, Athens, Greece, poster presentation. "Assessment of intrarenal venous flow can predict acute kidney injury in patients with acute heart failure." Sofia Sovetova'}, {'url': 'https://doi.org/10.1016/S0735-1097(24)02325-8', 'label': 'Sovetova, S, Andreev, D, Shchekochikhin, D. IMPACT OF RENAL BLOOD FLOW PATTERNS ON DIURETIC RESPONSE IN PATIENTS WITH ACUTE DECOMPENSATION OF HEART FAILURE. J Am Coll Cardiol. 2024 Apr, 83 (13\\_Supplement) 335'}]}, 'descriptionModule': {'briefSummary': 'The importance of assessing venous congestion in heart failure patients is widely acknowledged, but its study is hampered by the lack of a practical evaluation tool. Venous excess ultrasound score (VExUS) is a promising noninvasive ultrasound-guided modality that can detect and objectify clinically significant organ congestion. VExUS congestion grading score was still not formally validated in patients with AHF, as there is limited data on its clinical application in this group of patients.', 'detailedDescription': 'It is currently unknown whether changes in systemic venous congestion, assessed by venous excess ultrasound score (VExUS), are associated with worsening renal function, reduced diuretic and natriuretic response, and poor prognosis in patients with acute decompensation of heart failure (AHF).\n\nThis prospective, observational, single-center study included patients admitted to the intensive care unit with AHF. At admission all patients undergo bedside Doppler ultrasound of inferior vena cava, hepatic, portal and renal veins to determine blood flow patterns. Congestion was graded with the VExUS score (grade 0, grade 1, grade 2, grade 3). Sodium concentration in a spot urine sample was assessed in 1 hour after first standard intravenous loop diuretic administration. The primary endpoint was the development of acute kidney injury (AKI), defined as oligoanuria (diuresis rate \\<0.5 ml/kg/hour for 6 hours) and an increase of serum creatinine \\>26 µmol/l within a 48-hour period or 50% from baseline creatinine within a week. The secondary endpoints were in-hospital mortality, change in spot urine sodium content \\<50 mmol/l and development of diuretics resistance (defined as the need to double starting dose of intravenous furosemide in 6 hours without adding a different class of diuretic agents).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study involved patients over 18 years of age admitted to the hospital with AHF and requiring intravenous administration of loop diuretics. Diagnosis was based on the European Society of Cardiology (ESC) HF guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\>1000 pg/ml.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute decompensation of heart failure (diagnosis was based on the European Society of Cardiology (ESC) heart failure guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\> 1000 pg/ml\n\nExclusion Criteria:\n\n* Chronic renal replacement therapy or glomerular filtration rate \\< 15 ml/min/1.73m 2 (chronic kidney disease Epidemiology Collaboration (CKD)-EPI)\n* Cirrhosis with portal hypertension\n* Acute myocardial infarction according to The Fourth Universal Definition of Myocardial infarction\n* Pulmonary embolism\n* Sepsis (according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))\n* Endotracheal intubation at the time of admission\n* Pregnancy or breastfeeding\n* Aortic dissection\n* Active cancer\n* Neurological or mental disease during exacerbation\n* Refusal to sign an informed consent form, inadequate acoustic window'}, 'identificationModule': {'nctId': 'NCT06397404', 'briefTitle': 'VExUS in Patients With Acute Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'I.M. Sechenov First Moscow State Medical University'}, 'officialTitle': 'Congestion Assessment Using Venous Excess Ultrasound Score (VExUS) in Patients With Acute Heart Failure', 'orgStudyIdInfo': {'id': 'SS-DCFUD-02-2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with acute decompensated heart failure', 'description': 'The study involved patients over 18 years of age admitted to the hospital with acute heart failure and requiring intravenous administration of loop diuretics. Diagnosis was based on the European Society of Cardiology (ESC) heart failure guidelines, with patients presenting with dyspnoea at rest or with minimal exertion and signs and symptoms of congestion (rales on chest auscultation, peripheral oedema, swelling of the cervical veins, hepatomegaly, ascites, hepatojugular reflux) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\>1000 pg/ml.', 'interventionNames': ['Diagnostic Test: Venous excess ultrasound score (VExUS) protocol']}], 'interventions': [{'name': 'Venous excess ultrasound score (VExUS) protocol', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients upon admission undergo ultrasound assessment of diameter and collapsibility of the inferior vena cava, hepatic vein Doppler, portal vein Doppler, intra-renal venous Doppler.', 'armGroupLabels': ['Patients with acute decompensated heart failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '115446', 'city': 'Moscow', 'country': 'Russia', 'facility': 'City clinical hospital named after S. S. Yudin, Moscow City Health Department, Moscow, Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Sofia Sovetova', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'I.M. Sechenov First Moscow State Medical University (Sechenov University)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Local Ethics Committee policy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}