[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486222":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":37,"responsibleParty":58,"collaborators":60,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":12,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":12,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"No treatment group","NO_INTERVENTION","24 patients that will continue receiving routine treatment for PAH",null,{"label":14,"type":6,"description":15,"interventionNames":16},"Pentoxifylline","24 patients that will receive pentoxifylline and the routine treatment for PAH",[17],"Drug: Pentoxifylline",[19],{"type":20,"name":14,"description":21,"armGroupLabels":22,"otherNames":12},"DRUG","Oral Pentoxifylline 400 mg\u002Fday for 30 days, followed by 800 mg\u002Fday for 150 days",[14],[24],{"name":25,"affiliation":26,"role":27},"Antonio Augusto Barbosa Lopes, MD","InCor Heart Institute","PRINCIPAL_INVESTIGATOR",[29,33],{"name":25,"role":30,"phone":31,"phoneExt":12,"email":32},"CONTACT","+55 11 2661-5409","aablopes@usp.br",{"name":34,"role":30,"phone":35,"phoneExt":12,"email":36},"Mariana Cappelletti Galante, PharmD","+55112661-5709","Mariana.galante@hc.fm.usp.br",[38],{"facility":39,"status":40,"city":41,"state":12,"zip":12,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Antonio Augusto Barbosa Lopes","RECRUITING","São Paulo","Brazil","BR",{"type":45,"coordinates":46},"Point",[47,48],-46.63611,-23.5475,{"lat":48,"lon":47},[51,55],{"name":52,"role":30,"phone":53,"phoneExt":54,"email":36},"MarianaCappelletti Galante, PharmD","+55 11 2661-5709","PharmD",{"name":56,"role":57,"phone":12,"phoneExt":12,"email":12},"Nair Maeda, PhD","SUB_INVESTIGATOR",{"type":59,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[61],{"name":26,"class":6},"100486222","pentoxifylline-as-an-adjunct-therapy-for-patients-with-eisenmenger-syndrome-100486222",false,"NCT05611268","Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome","Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome: a Randomized Study","Inclusion Criteria:\n\n1. Eisenmenger syndrome in functional class II, III or IV (World Health Organization for Pulmonary Hypertension).\n2. Using or not oral anticoagulation with warfarin.\n\nExclusion Criteria:\n\n1. Hospitalized.\n2. History of relevant and\u002For repetitive bleeding.\n3. Relevant comorbidities with specific treatments.\n4. Systemic syndromes, except Down syndrome.\n5. Candidates for surgical treatment of any nature, except dental.\n6. Clinically manifest systemic infectious or inflammatory disease.\n7. Thrombocytopenia (\\\u003C80x10\\*9 platelets\u002FL).\n8. Patients in chronic anticoagulation regimen other than warfarin.\n9. Diabetics individuals.\n10. Pregnancy in progress, interruption of contraception or amenorrhea.\n11. History of intolerance of pentoxifylline or other xanthine derivatives.\n12. \"Creatinine clearance\" less than or equal to 30 mL\u002Fminute.","ALL","10 Years","80 Years",{"count":73,"type":74},48,"ESTIMATED","INTERVENTIONAL",[77],"NA","The Eisenmenger syndrome corresponds to the most advanced form of pulmonary arterial hypertension associated with congenital heart disease. The syndrome causes chronic hypoxemia, with an increase in erythrocyte mass, which predisposes to thrombotic complications. Pentoxifylline is a xanthine derivative and it is considered as a hemorrheological agent with described effects of reduction in erythrocyte and platelet aggregation, adhesion and activation of leukocytes, and endothelial damage. The main objective of this study is to verify if the chronic oral administration of pentoxifylline to Eisenmenger patients induces an increase in the circulating levels of thrombomodulin, a naturally occurring proteoglycan with anticoagulant, anti thrombotic and anti-inflammatory properties.",[80],"Eisenmenger Syndrome",[82,83,84,14,85,86],"Pulmonary Hypertension","Congenital Heart Disease","Thrombosis","Thrombomodulin","Tissue Factor","2023-12-14",{"date":89,"type":90},"2023-12-15","ACTUAL",{"date":92,"type":90},"2022-06-03",{"date":94,"type":74},"2026-09-30",{"name":5,"class":6},1]