[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658426":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":28,"overallOfficials":49,"centralContacts":53,"locations":28,"responsibleParty":62,"collaborators":65,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":126,"minAge":28,"maxAge":28,"enrollmentInfo":127,"targetDuration":130,"studyType":131,"phases":28,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":146,"whyStopped":28,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":28},{"fullName":5,"class":6},"IRCCS SYNLAB SDN","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"TAPSE\u002FsPAP ratio at rest and during exercise stress echocardiography","Tricuspid annular plane systolic excursion \u002F systolic pulmonary artery pressure (TAPSE\u002FsPAP) ratio, calculated by resting nd during exercise stress echocardiography as a non-invasive index of right ventricular-pulmonary arterial coupling.","Baseline",{"measure":14,"description":15,"timeFrame":12},"mPAP\u002FCO slope at rest and during exercise stress echocardiography","Slope of the relationship between mean pulmonary artery pressure (mPAP) and cardiac output (CO), derived at rest and during incremental exercise stress echocardiography as a non-invasive index of pulmonary vascular function.",[17,21,25],{"measure":18,"description":19,"timeFrame":20},"Incidence of the composite outcome of all-cause mortality or hospitalization for heart failure at follow-up","Number of participants experiencing the composite outcome of death from any cause or hospitalization for left or right heart failure, analyzed in relation to baseline right heart-pulmonary circulation unit (RH-PCU) functional indices.","1 year",{"measure":22,"description":23,"timeFrame":24},"Area under the ROC curve (AUC) of the TAPSE\u002FsPAP ratio for predicting the composite outcome of all-cause mortality or hospitalization for heart failure, compared with 2022 ESC\u002FERS Guideline risk-stratification thresholds","Receiver operating characteristic (ROC) curve analysis of the resting TAPSE\u002FsPAP ratio, assessing its diagnostic and prognostic discriminative ability for the long-term composite outcome (Outcome 3), and refinement of cut-off values relative to the risk-stratification thresholds defined in the 2022 ESC\u002FERS Guidelines for the diagnosis and treatment of pulmonary hypertension.","1 Year",{"measure":26,"description":27,"timeFrame":24},"Area under the ROC curve (AUC) of the mPAP\u002FCO slope for predicting the composite outcome of all-cause mortality or hospitalization for heart failure, compared with 2022 ESC\u002FERS Guideline risk-stratification thresholds","Receiver operating characteristic (ROC) curve analysis of the mPAP\u002FCO slope during exercise stress echocardiography, assessing its diagnostic and prognostic discriminative ability for the long-term composite outcome (Outcome 3), and refinement of cut-off values relative to the risk-stratification thresholds defined in the 2022 ESC\u002FERS Guidelines for the diagnosis and treatment of pulmonary hypertension.",null,{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":30,"timePerspective":6,"maskingInfo":28},"COHORT","The clinical and instrumental assessment of the right heart-pulmonary circulation unit is an essential step in the diagnostic, prognostic, and therapeutic algorithm of cardiorespiratory diseases. The original RIGHT-NET study demonstrated the relevance of physiological versus pathological responses through evaluation of the TAPSE\u002FsPAP ratio and mPAP\u002FCO slope during exercise stress echocardiography, both of which carry prognostic significance and predict all-cause mortality across healthy subjects, athletes, high-altitude residents, and patients with cardiopulmonary disease.\n\nStudy objectives include advancing understanding of RH-PCU physiology and pathophysiology during exercise, assessing the discriminative capacity of TAPSE\u002FsPAP and mPAP\u002FCO slope across clinical conditions, investigating associations between RH-PCU functional indices and short-, medium-, and long-term clinical outcomes including all-cause mortality, refining diagnostic and prognostic thresholds in line with the 2022 ESC\u002FERS guidelines, and building a standardized dataset via REDCap.\n\nFor each participant, demographic, anthropometric, and clinical characteristics will be collected, together with laboratory tests, invasive and non-invasive diagnostic procedures (including right heart catheterization, cardiac MRI, nuclear diagnostics, and arterial blood gas analysis), therapy data, and clinical outcomes. Data will be analyzed using R (version \\>= 4.3.1) with descriptive statistics, group comparisons, univariate and multivariate regression models, and supervised machine learning techniques (random forest, gradient boosting, support vector machine) for predictive modeling.\n\nAs an observational study, participation does not alter the participant's diagnostic or therapeutic pathway, and no additional insurance coverage beyond standard clinical practice is required.","Patients referred, as part of their routine clinical pathway, to cardiology, internal medicine, echocardiography, or exercise testing (ergometry) laboratories at the participating centers, selected based on a documented clinical indication for right heart-pulmonary circulation unit assessment as determined by the referring physician, and classified according to the 2022 ESC\u002FERS Guidelines for the diagnosis and treatment of pulmonary hypertension. The population also includes healthy volunteers, including individuals undergoing occupational fitness assessment; individuals with cardiovascular risk factors but no overt cardiopulmonary disease; athletes referred for sports eligibility evaluation; and healthy individuals living at high altitude.",[34,37,40,43,46],{"label":35,"type":28,"description":36,"interventionNames":28},"Patients with Clinical Indication for RH-PCU Assessment","Patients referred, as part of their routine clinical pathway, to cardiology, internal medicine, echocardiography, or exercise testing laboratories for evaluation of right heart-pulmonary circulation unit function, based on a documented clinical indication as determined by the referring physician. Patients are classified according to the 2022 ESC\u002FERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Intervention\u002Fexposure of interest: rest and exercise stress transthoracic color-Doppler echocardiography (ExTTE); additional non-invasive and invasive diagnostic procedures (right heart catheterization, cardiac MRI, nuclear diagnostics, arterial blood gas analysis) are performed where clinically indicated, as part of standard care.",{"label":38,"type":28,"description":39,"interventionNames":28},"Healthy Volunteers","Healthy individuals enrolled as volunteers or referred for assessment of fitness for work, with no known cardiopulmonary disease. Intervention\u002Fexposure of interest: rest and exercise stress transthoracic echocardiography (ExTTE), performed as part of the study assessment.",{"label":41,"type":28,"description":42,"interventionNames":28},"Subjects with Cardiovascular Risk Factors","Individuals presenting cardiovascular risk factors (e.g. hypertension, dyslipidemia, obesity, diabetes) but without overt cardiovascular or respiratory disease. Intervention\u002Fexposure of interest: rest and exercise stress transthoracic echocardiography (ExTTE), performed as part of the study assessment.",{"label":44,"type":28,"description":45,"interventionNames":28},"Athletes Undergoing Sports Eligibility Evaluation","Athletes referred to participating centers for evaluation of fitness for competitive or amateur sports activity. Intervention\u002Fexposure of interest: rest and exercise stress transthoracic echocardiography (ExTTE), performed as part of the study assessment.",{"label":47,"type":28,"description":48,"interventionNames":28},"Healthy Subjects Living at High Altitude","Healthy individuals residing at high altitude, included to characterize right heart-pulmonary circulation unit adaptation to chronic hypoxic exposure. Intervention\u002Fexposure of interest: rest and exercise stress transthoracic echocardiography (ExTTE), performed as part of the study assessment.",[50],{"name":51,"affiliation":5,"role":52},"Marco Salvatore, MD,PhD","PRINCIPAL_INVESTIGATOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":28,"email":58},"Anna D'Agostino, PhD","CONTACT","‪+39 345 355 6702‬","anna.dagostino@synlab.it",{"name":60,"role":56,"phone":57,"phoneExt":28,"email":61},"Mario Zanfardino, PhD","mario.zanfardino@synlab.it",{"type":52,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Marco Salvatore","Scientific Director",[66,68,71,73,75,77,79,81,83,85,87,89,91,93,95,97,99,101,103,105,107,109,111,113,115],{"name":67,"class":6},"University of Pisa",{"name":69,"class":70},"Institute of Clinical Physiology, CNR, Pisa","UNKNOWN",{"name":72,"class":6},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"name":74,"class":6},"University of Milan",{"name":76,"class":6},"IRCCS Multimedica",{"name":78,"class":6},"University Of Perugia",{"name":80,"class":6},"ASST Grande Ospedale Metropolitano Niguarda",{"name":82,"class":6},"IRCCS Ospedale San Raffaele",{"name":84,"class":6},"University of Padova",{"name":86,"class":6},"Federico II University",{"name":88,"class":6},"University of Molise",{"name":90,"class":6},"University of Trieste",{"name":92,"class":6},"Medical University of Graz",{"name":94,"class":6},"Ohio State University",{"name":96,"class":70},"Jewish General Hospital (Montreal, Quebec, Canada)",{"name":98,"class":6},"Universitat Politècnica de Catalunya",{"name":100,"class":6},"University Hospital Heidelberg",{"name":102,"class":70},"Institute of Family Medicine, University of Szeged, Hungary",{"name":104,"class":6},"Medical University of Lodz",{"name":106,"class":70},"Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno",{"name":108,"class":70},"CRO \"Centro Clinical Trials\" IRCCS Ospedale Policlinico San Martino",{"name":110,"class":6},"Umberto I Hospital, Nocera Inferiore",{"name":112,"class":6},"Azienda Sanitaria Universitaria Friuli Centrale",{"name":114,"class":6},"Cardarelli Hospital",{"name":116,"class":6},"Azienda Ospedaliera dei Colli","100658426","right-heart-and-lung-blood-flow-during-exercise-right-net-20-100658426",false,"NCT07851610","Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0)","The Right Heart International NETwork 2.0 (RIGHT-NET 2.0)","RIGHT-NET 2","Inclusion Criteria\n\n* Patients referred as part of their routine clinical pathway for evaluation in cardiology, internal medicine, echocardiography, or exercise testing laboratories, with a documented clinical indication for assessment of right heart-pulmonary circulation unit function, as determined by the referring physician\n* Classified according to the 2022 ESC\u002FERS Guidelines for the diagnosis and treatment of pulmonary hypertension\n* Healthy volunteers, including individuals undergoing occupational fitness assessment\n* Individuals with cardiovascular risk factors but no overt cardiopulmonary disease\n* Athletes referred for sports eligibility evaluation\n* Healthy individuals living at high altitude\n* Clinically stable at the time of enrollment\n* Provision of consent to the processing of personal data in anonymous and aggregated form\n\nExclusion Criteria\n\n* Active oncological disease\n* Clinical conditions incompatible with the execution of exercise stress echocardiography (e.g., inability to perform physical exercise, severe musculoskeletal limitations, unstable angina, recent acute myocardial infarction, uncontrolled arrhythmias)\n* Current pregnancy\n* Any other condition judged by the referring physician to be incompatible with participation in the study",true,"ALL",{"count":128,"type":129},2000,"ESTIMATED","12 Months","OBSERVATIONAL","RIGHT-NET 2.0 is a multicenter observational study with a retrospective-prospective design that builds on the original RIGHT-NET study. It aims to observe and document the functional status of the right heart-pulmonary circulation unit (RH-PCU) at rest and during exercise stress transthoracic echocardiography (ExTTE) in clinically stable patients referred to cardiology, internal medicine, echocardiography, and exercise testing laboratories. The study will also include healthy volunteers, individuals with cardiovascular risk factors but no overt disease, athletes undergoing sports eligibility evaluation, and healthy individuals living at high altitude. Patients will be classified according to the 2022 ESC\u002FERS Guidelines for the diagnosis and treatment of pulmonary hypertension. The study plans to enroll at least 1000 additional subjects beyond the original RIGHT-NET cohort of 1000 participants, for a total anticipated enrollment of approximately 2000 subjects across 22 Italian and 16 international centers. Data will be collected through the REDCap electronic data capture platform in a pseudonymized format.",[134,135,136],"Right Ventricular Dysfunction","Cardiopulmonary Diseases","Pulmonary Hypertension",[138,139,140,141,142,143,144,145],"Pulmonary hypertension","Right ventricular function","Exercise stress echocardiography","TAPSE\u002FsPAP ratio","mPAP\u002FCO slope","Right heart catheterization","Cardiopulmonary exercise testing","Athletes","NOT_YET_RECRUITING","2026-09-25",{"date":149,"type":150},"2026-10-01","ACTUAL",{"date":152,"type":129},"2027-01-01",{"date":154,"type":129},"2036-12",{"name":5,"class":6}]