[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631869":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":289,"collaborators":25,"id":291,"slug":292,"hasResults":293,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":293,"sex":298,"minAge":299,"maxAge":25,"enrollmentInfo":300,"targetDuration":25,"studyType":303,"phases":304,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":320,"whyStopped":25,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":330},{"fullName":5,"class":6},"University Hospital, Angers","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Home treatment","EXPERIMENTAL","Patients randomized to this arm are managed as outpatients and discharged early after inclusion, no later than 24 hours after inclusion and no later than 48 hours after presentation to the emergency department. Anticoagulation therapy is initiated prior to discharge and continued in accordance with current guidelines and local practice. Patients receive structured follow-up in accordance with current guidelines and are instructed to seek medical attention in case of clinical deterioration, suspected recurrence of venous thromboembolism, or bleeding.",[13],"Other: Home treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Hospitalization","ACTIVE_COMPARATOR","Patients randomized to this arm are managed as inpatients and admitted to a hospital medical unit for the management of acute PE according to local organization. Anticoagulation therapy is initiated and managed in accordance with current guidelines and local practice. The duration of hospitalization and timing of discharge are left to the discretion of the treating physician. Patients receive structured follow-up in accordance with current guidelines and are instructed to seek medical attention in case of clinical deterioration, suspected recurrence of venous thromboembolism, or bleeding.",[19],"Other: Hospitalization",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"OTHER","Outpatient management strategy for acute pulmonary embolism, including early discharge after diagnosis and initiation of anticoagulation therapy, with follow-up according to current guidelines and local practice.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Inpatient management strategy for acute pulmonary embolism, including hospital admission and standard care with anticoagulation therapy according to current guidelines and local practice.",[15],[30],{"name":31,"affiliation":32,"role":33},"Pierre-Marie ROY, Professor","University Hospital of Angers, France","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+ 33 (0)2 41 35 37 18","PMRoy@chu-angers.fr",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Matthieu LE LAY","+33 (0)2 41 35 58 91","DRCI-Promotion-Interne@chu-angers.fr",[44,59,73,87,101,115,128,142,156,170,184,198,209,220,233,247,261,275],{"facility":45,"status":25,"city":46,"state":25,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Angers University Hospital, Emergency Department","Angers","49000","France","FR",{"type":51,"coordinates":52},"Point",[53,54],-0.55202,47.47156,{"lat":54,"lon":53},[57],{"name":31,"role":36,"phone":58,"phoneExt":25,"email":38},"+33 (0)2 41 35 37 18",{"facility":60,"status":25,"city":61,"state":25,"zip":62,"country":48,"countryCode":49,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Argenteuil hospital, Emergency department","Argenteuil","95100",{"type":51,"coordinates":64},[65,66],2.24744,48.94788,{"lat":66,"lon":65},[69],{"name":70,"role":36,"phone":71,"phoneExt":25,"email":72},"Catherine Le Gall, Doctor","0134232425","catherine.legall@ch-argenteuil.fr",{"facility":74,"status":25,"city":75,"state":25,"zip":76,"country":48,"countryCode":49,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Brest University Hospital (site Cavale Blanche), Cardiology Department","Brest","29200",{"type":51,"coordinates":78},[79,80],-4.48628,48.39029,{"lat":80,"lon":79},[83],{"name":84,"role":36,"phone":85,"phoneExt":25,"email":86},"Francis COUTURAUD, Professor","+33 (0)2.98.34.73.47","francis.couturaud@chu-brest.fr",{"facility":88,"status":25,"city":89,"state":25,"zip":90,"country":48,"countryCode":49,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Cholet Hospital, Emergency department","Cholet","49300",{"type":51,"coordinates":92},[93,94],-0.87974,47.05893,{"lat":94,"lon":93},[97],{"name":98,"role":36,"phone":99,"phoneExt":25,"email":100},"Caroline Soulie, Doctor","0241496985","caroline.soulie-chavignon@ch-cholet.fr",{"facility":102,"status":25,"city":103,"state":25,"zip":104,"country":48,"countryCode":49,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Clermont-Ferrand University Hospital, Emergency department","Clermont-Ferrand","63000",{"type":51,"coordinates":106},[107,108],3.08682,45.77969,{"lat":108,"lon":107},[111],{"name":112,"role":36,"phone":113,"phoneExt":25,"email":114},"Jeannot SCHMIDT, Professor","+33 (0)4 73 75 45 49","jschmidt@chu-clermontferrand.fr",{"facility":116,"status":25,"city":117,"state":25,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Paris University Hospital (APHP - site Louis Mourier), Emergency Department","Colombes",{"type":51,"coordinates":119},[120,121],2.25404,48.91882,{"lat":121,"lon":120},[124],{"name":125,"role":36,"phone":126,"phoneExt":25,"email":127},"Nicolas JAVAUD, Professor","+33 (0)6 73 87 29 72","nicolas.javaud@aphp.fr",{"facility":129,"status":25,"city":130,"state":25,"zip":131,"country":48,"countryCode":49,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Grenoble University Hospital, Emergency Department","Grenoble","38000",{"type":51,"coordinates":133},[134,135],5.71479,45.17869,{"lat":135,"lon":134},[138],{"name":139,"role":36,"phone":140,"phoneExt":25,"email":141},"Damien Viglino, Professor","0476766784","dviglino@chu-grenoble.fr",{"facility":143,"status":25,"city":144,"state":25,"zip":145,"country":48,"countryCode":49,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Le Mans Hospital, Emergency department","Le Mans","72000",{"type":51,"coordinates":147},[148,149],0.20251,48.0021,{"lat":149,"lon":148},[152],{"name":153,"role":36,"phone":154,"phoneExt":25,"email":155},"Cyrielle Houalard, Doctor","0243434343","cyrielle.houalard@gmail.com",{"facility":157,"status":25,"city":158,"state":25,"zip":159,"country":48,"countryCode":49,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Lyon University Hospital (site Edouard Herriot), Emergency Department","Lyon","69003",{"type":51,"coordinates":161},[162,163],4.84789,45.74906,{"lat":163,"lon":162},[166],{"name":167,"role":36,"phone":168,"phoneExt":25,"email":169},"Antonin THIBIEROZ, Doctor","+33 (0)4.72.11.22.93","youri.yordanov@chu-lyon.fr",{"facility":171,"status":25,"city":172,"state":25,"zip":173,"country":48,"countryCode":49,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Nantes University Hospital, Emergency department","Nantes","44000",{"type":51,"coordinates":175},[176,177],-1.55336,47.21725,{"lat":177,"lon":176},[180],{"name":181,"role":36,"phone":182,"phoneExt":25,"email":183},"François Javaudin, Doctor","0240083333","Francois.JAVAUDIN@chu-nantes.fr",{"facility":185,"status":25,"city":186,"state":25,"zip":187,"country":48,"countryCode":49,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Paris University Hospital (APHP - site Lariboisière hospital), emergency department","Paris","75010",{"type":51,"coordinates":189},[190,191],2.3488,48.85341,{"lat":191,"lon":190},[194],{"name":195,"role":36,"phone":196,"phoneExt":25,"email":197},"Anthony Chauvin, Professor","+33 (0)149956565","anthony.chauvin@aphp.fr",{"facility":199,"status":25,"city":186,"state":25,"zip":200,"country":48,"countryCode":49,"cosmosGeoPoint":201,"geoPoint":203,"contacts":204},"Paris University Hospital (APHP - site La Pitié-Salpétrière Hospital), Emergency Department","75013",{"type":51,"coordinates":202},[190,191],{"lat":191,"lon":190},[205],{"name":206,"role":36,"phone":207,"phoneExt":25,"email":208},"Yonathan Freund, Doctor","+33 (0)1 42 16 00 00","yonathan.freund@aphp.fr",{"facility":210,"status":25,"city":186,"state":25,"zip":211,"country":48,"countryCode":49,"cosmosGeoPoint":212,"geoPoint":214,"contacts":215},"Paris University Hospital (APHP - site HEGP), Emergency Department","75015",{"type":51,"coordinates":213},[190,191],{"lat":191,"lon":190},[216],{"name":217,"role":36,"phone":218,"phoneExt":25,"email":219},"Richard Chocron, Professor","+33 (0)156095876","richard.chocron@aphp.fr",{"facility":221,"status":25,"city":186,"state":25,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":222,"geoPoint":224,"contacts":225},"Paris University Hospital (APHP, site Hôpital Européen Georges Pompidou), Pneumology department",{"type":51,"coordinates":223},[190,191],{"lat":191,"lon":190},[226,230],{"name":227,"role":36,"phone":228,"phoneExt":25,"email":229},"Olivier SANCHEZ, MD.PhD","+33 (0)1 56 09 34 87","olivier.sanchez@aphp.fr",{"name":231,"role":36,"phone":25,"phoneExt":25,"email":232},"Anne-Laure FERAL, MD","anne-laure.feral-pierssens@aphp.fr",{"facility":234,"status":25,"city":235,"state":25,"zip":236,"country":48,"countryCode":49,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Lyon University Hospital (site Lyon Sud), Emergency department","Pierre-Bénite","69495",{"type":51,"coordinates":238},[239,240],4.82424,45.70359,{"lat":240,"lon":239},[243],{"name":244,"role":36,"phone":245,"phoneExt":25,"email":246},"Marion Douplat, Doctor","+33 (0)478862854","marion.douplat@chu-lyon.fr",{"facility":248,"status":25,"city":249,"state":25,"zip":250,"country":48,"countryCode":49,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Poitiers University Hospital, Emergency Department","Poitiers","86000",{"type":51,"coordinates":252},[253,254],0.34348,46.58261,{"lat":254,"lon":253},[257],{"name":258,"role":36,"phone":259,"phoneExt":25,"email":260},"Nicolas Marjanovic, Doctor","+33 (0)5.49.44.44.44","nicolas.marjanovic@chu-poitiers.fr",{"facility":262,"status":25,"city":263,"state":25,"zip":264,"country":48,"countryCode":49,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Rouen University Hospital, Emergency Department","Rouen","76000",{"type":51,"coordinates":266},[267,268],1.09932,49.44313,{"lat":268,"lon":267},[271],{"name":272,"role":36,"phone":273,"phoneExt":25,"email":274},"Mélanie Roussel, Doctor","0232881879","melanie.roussel@chu-rouen.fr",{"facility":276,"status":25,"city":277,"state":25,"zip":278,"country":48,"countryCode":49,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Toulouse University Hospital, Emergency Department","Toulouse","31000",{"type":51,"coordinates":280},[281,282],1.44367,43.60426,{"lat":282,"lon":281},[285],{"name":286,"role":36,"phone":287,"phoneExt":25,"email":288},"Felipe GUERRERO, Doctor","+33 (0)5 61 32 22 71","guerrero.f@chu-toulouse.fr",{"type":290,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100631869","home-pe2--home-treatment-versus-hospitalization-in-patients-with-acute-pulmonary-embolism-no-clinical-severity-criteria-and-either-right-ventricular-dysfunction-or-elevated-troponin-a-randomized-controlled-trial-100631869",false,"NCT07506291","HOME-PE2 : Home Treatment Versus Hospitalization in Patients With Acute Pulmonary Embolism, no Clinical Severity Criteria, and Either Right Ventricular Dysfunction or Elevated Troponin: a Randomized Controlled Trial","HOME-PE2","Inclusion Criteria:\n\n* Presentation to the Emergency Department or unscheduled consultation in one of the participating centers\n* Symptomatic PE objectively confirmed according to the European Society of Cardiology criteria 4 (either by i) a high-probability ventilation\u002Fperfusion lung scan, ii) a new contrast filling defect on spiral computed tomography, or iii) a new documentation by ultrasonography of a proximal DVT, i.e., thrombus in the popliteal vein or above, along with clinical signs of PE. All radiological tests used to diagnose PE will be interpreted by on-site radiologists or angiologists)\n* No clinical criteria mandating hospitalization according to the Hestia rule, i.e., negative Hestia rule\n* Right ventricular dysfunction - defined as a right ventricular (RV) to left ventricular (LV) diameter ratio \\> 1.0 on echocardiography (apical four-chamber or subcostal four-chamber view) or on CTPA (transverse plane) OR High-sensibility cardiac troponin I or T concentration above the upper limit of local normal value\n* Insurance cover according to local legislation\n* Age ≥18 years\n* Signed free informed consent (or oral consent if possible according to local regulation).\n\nExclusion Criteria:\n\n* Shock or hypotension (defined as systolic blood pressure \\\u003C90 mmHg or a systolic pressure drop by ≥40 mmHg, for \\>15 minutes, if not caused by new-onset arrhythmia, hypovolemia, or sepsis)\n* Combined right ventricular dysfunction (RV\u002FLV \\> 1.0 on imaging) AND troponin concentration above the upper limit of local normal value\n* Free floating thrombi in the right atrium or ventricle, if identified by routine echocardiography or CTPA\n* Active cancer other than basal or squamous-cell skin cancer defined at least with one of the following: i) cancer diagnosed within the last 6 months, ii) current anti-cancer treatment or during the 6 months before enrollment, iii) locally advanced or metastatic cancer\n* PE diagnosis established since more than 24 hours\n* 48 hours or more elapsed between ED presentation and potential inclusion or other reason making home discharge impossible within the 48 hours since ED presentation\n* Limited life expectancy or any other reason making 3-month follow-up impossible\n* Pregnant or parturient patient\n* Patient in detention by judicial or administrative decision, under a legal protection measure or undergoing compulsory psychiatric treatment","ALL","18 Years",{"count":301,"type":302},568,"ESTIMATED","INTERVENTIONAL",[305],"NA","This study (HOME-PE2) is a multicenter, randomized controlled trial comparing home treatment versus hospitalization in patients with acute pulmonary embolism (PE) who have no clinical severity criteria according to the Hestia rule but present either right ventricular dysfunction or elevated cardiac troponin levels.\n\nWhile outpatient management is considered safe for low-risk PE patients, the optimal management of patients without clinical severity but with signs of right ventricular strain or myocardial injury remains uncertain, and current guidelines are inconsistent. As a result, most of these patients are still hospitalized despite limited evidence supporting this approach.\n\nThe primary objective is to assess whether home treatment is non-inferior to hospitalization in terms of safety, defined by the 7-day rate of adverse events according to the EARTH consensus. Secondary objectives include evaluation of net clinical benefit, quality of life, functional status, and healthcare resource utilization, as well as exploration of sex-related differences and cost-effectiveness.\n\nA total of 568 adult patients with confirmed PE will be randomized (1:1) to either home treatment with early discharge or standard hospitalization. Patients will be followed for 90 days.",[308],"Acute Pulmonary Embolism",[310,311,9,15,312,313,314,315,316,317,318,319],"pulmonary embolism","Outpatient treatment","Hestia rule","Right ventricular dysfunction","Troponin","Risk stratification","Randomized controlled trial","Quality of life","Functional status","Health economics","NOT_YET_RECRUITING","2026-03-26",{"date":323,"type":324},"2026-04-01","ACTUAL",{"date":326,"type":302},"2026-06",{"date":328,"type":302},"2029-09",{"name":5,"class":6},18]