[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07222813":3,"trial-entities:NCT07222813":193,"trial-summary:NCT07222813":196},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":54,"secondary_outcomes":62,"sex":80,"minimum_age":81,"maximum_age":82,"healthy_volunteers":15,"eligibility_criteria":83,"std_ages":87,"locations":90,"central_contacts":185,"overall_officials":190,"references":191,"see_also_links":192},"NCT07222813","Cs002","Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP)","Performance of Liver Stiffness Measurement (LSM) by FibroScan® for the Diagnosis of Elevated Central Venous Pressure (CVP)","NOT_YET_RECRUITING","2027-01-15","2025-10","2025-10-30","2026-01-15","Echosens","INDUSTRY",false,"This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation designed to explore a non-invasive, reliable alternative to invasive, catheter-based hemodynamic assessments, which are associated with procedural risks and limited applicability in certain participant populations.","CHF, as defined by the American College of Cardiology and the American Heart Association, is \"a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood.\" These patients will often develop congestion that may require urgent hospitalization, especially if pulmonary congestion is present. However, congestion can be difficult to assess, especially when symptoms are mild, or in patients nearing discharge from an HF hospitalization.8 Increased cardiac filling pressures, including the CVP, often silently precede the appearance of congestive symptoms by days resulting in hepatic congestion.\n\nInvasive methods, such as RHC, remain the gold standard method of measuring CVP, offering accurate and direct hemodynamic data. However, RHC requires specialized training and invasive vascular access and is associated with procedural risks including bleeding, infection, arrhythmia, and patient discomfort.\n\nEchocardiography is the most common non-invasive adjunct tool for estimating CVP and assessing cardiac function. It evaluates indirect parameters, right atrial size, IVC diameter, and collapsibility to detect elevated CVP.\n\nLSM by VCTE™ has emerged as a novel non-invasive approach to detecting elevated CVP indirectly. Liver elastography relies on imaging techniques to assess LSM, with high values equating to increased stiffness. While this was developed to assess fibrosis in chronic liver diseases, LSM also reflects increased CVP and hepatic congestion. Multiple studies have shown promising correlations between increased liver stiffness and invasively measured CVP, indicating a potential clinical strategy for detecting hemodynamic congestion non-invasively.\n\nGiven these considerations, the current clinical investigation aims to evaluate the 13.3 kPa cutoff performance of LSM with FibroScan (Echosens, Paris, France) to diagnose elevated CVP (\\>10 mm Hg).",[19,20],"Heart Failure","Heart Failure - NYHA II - IV",[22,23,24,25],"Fibroscan","Vibration Control Transient Elastography","Liver Stiffness Measurement","Guided VCTE","INTERVENTIONAL","DIAGNOSTIC",[29],"NA",{"count":31,"type":32},149,"ESTIMATED",[34,40,45,49],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","FibroScan","At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM)",[39],"Full Cohort",{"type":41,"name":42,"description":43,"armGroupLabels":44},"PROCEDURE","Right-sided Heart Catheterization","at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP)",[39],{"type":41,"name":46,"description":47,"armGroupLabels":48},"Transthoracic echocardiography","at Day 0 assessment of cardiac function",[39],{"type":50,"name":51,"description":52,"armGroupLabels":53},"BIOLOGICAL","Blood Sample Analysis","At Day0: To assess baseline organ function that may impact participant safety, and blood samples for clinical laboratory tests",[39],[55,59],{"measure":56,"description":57,"timeFrame":58},"Proportion of individuals with elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Sensitivity]","Sensitivity (true positive rate) = TP \u002F (TP + FN)","at Day 0",{"measure":60,"description":61,"timeFrame":58},"Proportion of individuals without elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Specificity]","Specificity (1 - false negative rate) = TN \u002F (TN + FP)",[63,65,67,69,72,74,76,78],{"measure":64,"timeFrame":58},"Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of elevated CVP (>10 mm Hg)",{"measure":66,"timeFrame":58},"Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of abnormal IVC diameter",{"measure":68,"timeFrame":58},"Logistic regression model to identify clinical, laboratory, and echocardiographic factors associated with LSM\u002FCVP discordance.",{"measure":70,"description":71,"timeFrame":58},"Correlation between LSM and echocardiographic parameters evaluated with Pearson or Spearman correlation coefficients","* Unit of measure: Pearson or Spearman coefficient\n* Measurement tool: linear regression",{"measure":73,"description":71,"timeFrame":58},"Correlation between LSM and NT-proBNP evaluated with Pearson or Spearman correlation coefficients",{"measure":75,"description":71,"timeFrame":58},"Correlation between LSM and CA-125 evaluated with Pearson or Spearman correlation coefficients",{"measure":77,"description":71,"timeFrame":58},"Correlation between LSM and clinical parameters evaluated with Pearson or Spearman correlation coefficients",{"measure":79,"timeFrame":58},"Proportion of individuals correctly identified for the diagnosis of elevated CVP (>10 mm Hg) compared between LSM, echocardiography parameter and NT-proBNP using DeLong's test for correlated ROC curves","ALL","18 Years",null,{"inclusion":84,"exclusion":85,"raw_text":86},[],[],"Inclusion Criteria:\n\n1. Have read, understood, and signed the informed consent form (ICF)\n2. Be ≥18 years of age at the time of screening\n3. Have suspected or diagnosed acute or chronic HF and be scheduled to undergo right-sided cardiac catheterization\n\nExclusion Criteria:\n\n1. Inability to consent\n2. Chronic liver disease (self-reported alcohol use \\>14 drinks\u002Fweek in females and \\>21 drinks\u002Fweek in males), positive hepatitis C virus serology, positive hepatitis B surface antigen, autoimmune hepatitis, hemochromatosis, or cholestatic disease)\n3. BMI \\>40 kg\u002Fm2\n4. Fontan-type circulation\n5. Ascites\n6. Heart transplantation\n7. Pregnancy, breastfeeding, or intent to become pregnant during the study\n8. Intent to donate\u002Fbank or retrieve eggs (ova, oocytes) or donate sperm during the study",[88,89],"ADULT","OLDER_ADULT",[91,106,119,132,145,159,172],{"facility":92,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":103},"Keck Medicine of USC-Norris Healthcare Center - Transplant Clinic","Los Angeles","California","90033","United States",[98],{"name":99,"role":100,"phoneExt":101,"email":102},"Michael Fong, MD","CONTACT","323-442-8437","michael.fong@usc.edu",{"lat":104,"lon":105},34.05223,-118.24368,{"facility":107,"city":108,"state":109,"zip":110,"country":96,"contacts":111,"geoPoint":116},"University of Minnesota","Minneota","Minnesota","55455",[112],{"name":113,"role":100,"phone":114,"email":115},"Tamas Alexy, MD","612-626-1240","alexy001@umn.edu",{"lat":117,"lon":118},44.55885,-95.98559,{"facility":120,"city":121,"state":122,"zip":123,"country":96,"contacts":124,"geoPoint":129},"Medical University of South Carolina","Charleston","South Carolina","29425",[125],{"name":126,"role":100,"phone":127,"email":128},"Michele Esposito, MD","843-792-1105","espositm@musc.edu",{"lat":130,"lon":131},32.77632,-79.93275,{"facility":133,"city":134,"state":135,"zip":136,"country":96,"contacts":137,"geoPoint":142},"University of Texas Southwestern Medical Center - Clinical Heart and Vascular Center - West Campus Building 3 Location","Dallas","Texas","75390",[138],{"name":139,"role":100,"phone":140,"email":141},"Ambarish Pandey, MD, MSCS, FAHA","214-645-2101","ambarish.pandey@utsouthwestern.edu",{"lat":143,"lon":144},32.78306,-96.80667,{"facility":146,"city":147,"state":148,"zip":149,"country":150,"contacts":151,"geoPoint":156},"Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou","Rennes","Ile Et Vilaine","35000","France",[152],{"name":153,"role":100,"phone":154,"email":155},"Erwan Donal, MD","33617708567","erwan.donal@chu-rennes.fr",{"lat":157,"lon":158},48.11109,-1.67431,{"facility":160,"city":161,"zip":162,"country":163,"contacts":164,"geoPoint":169},"Deutsches Herzzentrum der Charité (DHZC) - Klinik fuer Herz-, Thorax- und Gefaesschirurgie","Berlin","13353","Germany",[165],{"name":166,"role":100,"phone":167,"email":168},"Felix Schoenrath, MD","4.93046E+11","felix.schoenrath@dhzc-charite.de",{"lat":170,"lon":171},52.52437,13.41053,{"facility":173,"city":174,"state":175,"country":176,"contacts":177,"geoPoint":182},"Uniwersytet Medyczny im. Piastow Slaskich we Wroclawiu, Instytut Chorob Serca","Wroclaw","Basse-Silésie","Poland",[178],{"name":179,"role":100,"phone":180,"email":181},"Jan Biegus, MD","48606674114","janbiegus@gmail.com",{"lat":183,"lon":184},51.10286,17.03006,[186],{"name":187,"role":100,"phone":188,"email":189},"CAROLE MEILLEROUX, PharmD","+33622649277","carole.meilleroux@echosens.com",[],[],[],{"nct_id":4,"conditions":194,"biomarkers":195},[19],[],{"nct_id":4,"found":197,"summary":198,"prompt_version":208},true,{"design":199,"status":200,"heading":201,"summary":202,"follow_up":203,"word_count":204,"commitments":205,"compensation":206,"drugs_mentioned":207},"This is a global, multi-center study aiming to enroll 149 participants. It is designed to compare a non-invasive test to a standard invasive procedure.","completed","FibroScan for Detecting Elevated Central Venous Pressure in Heart Failure","This study is looking at whether a non-invasive test called FibroScan can accurately detect high central venous pressure (CVP) in people with heart failure. CVP is a measure of pressure in the large veins near the heart. Currently, the best way to measure CVP is with a procedure called right-sided heart catheterization (RHC), which involves inserting a tube into a vein. FibroScan uses sound waves to measure liver stiffness, which might be linked to high CVP. You could join if you are 18 or older, have suspected or diagnosed heart failure, and are already scheduled for an RHC. The study will compare FibroScan results to RHC results to see how well FibroScan identifies high CVP. The study's status is unclear.","The primary measurements for this study are taken at Day 0.",120,"You would have a FibroScan examination, a right-sided heart catheterization, a transthoracic echocardiography, and blood samples taken on Day 0.","Not stated in the trial record.",[36,42],"v2"]