[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647917":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":46,"responsibleParty":63,"collaborators":44,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":44,"enrollmentInfo":76,"targetDuration":44,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":48,"whyStopped":44,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Triple Therapy Escalation (Inhaled Iloprost or Selexipag)","EXPERIMENTAL","Participants will receive escalation to triple therapy through addition of a prostacyclin pathway agent (inhaled iloprost or selexipag) to ongoing dual therapy with an endothelin receptor antagonist and sildenafil. The specific prostacyclin pathway agent will be selected according to clinical judgment and availability. Participants will remain on triple therapy during follow-up unless modification is clinically indicated.",[13],"Drug: Prostacyclin Pathway Agent",{"label":15,"type":16,"description":17,"interventionNames":18},"Sildenafil Dose Optimization","ACTIVE_COMPARATOR","Participants will continue dual therapy with an endothelin receptor antagonist and sildenafil, with optimization of sildenafil dose according to clinical practice. No additional pulmonary arterial hypertension pathway agent will be added at randomization. Treatment adjustments after randomization will be recorded if clinically required.",[19],"Drug: Sildenafil Dose Optimization",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Prostacyclin Pathway Agent","Addition of a prostacyclin pathway agent (inhaled iloprost or oral selexipag) to ongoing dual therapy with an endothelin receptor antagonist and sildenafil as part of therapeutic escalation to triple therapy. The specific agent will be selected according to clinical judgment and availability. Dosing will follow approved labeling and routine clinical practice.",[9],[27,28],"Iloprost","Selexipag",{"type":22,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"Optimization of sildenafil dose within approved dosing ranges as part of dual therapy with an endothelin receptor antagonist. Dose adjustments will be performed according to clinical practice to achieve maximal tolerated and guideline-recommended dosing without addition of a new PAH pathway agent at randomization.",[15],[33],"Sildenafil",[35],{"name":36,"affiliation":37,"role":38},"Caio Fernandes","Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo","PRINCIPAL_INVESTIGATOR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Caio Fernandes, MD, PhD","CONTACT","+551126615034",null,"cjcfernandes@yahoo.com.br",[47],{"facility":37,"status":48,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","São Paulo","04551-060","Brazil","BR",{"type":54,"coordinates":55},"Point",[56,57],-46.63611,-23.5475,{"lat":57,"lon":56},[60],{"name":61,"role":42,"phone":62,"phoneExt":44,"email":45},"Caio Fernandes, Principal Investigator","1126615034",{"type":38,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Caio Júlio César dos Santos Fernandes","Principal Investigator","100647917","phase-4-randomized-study-of-triple-therapy-vs-sildenafil-dose-optimization-in-pulmonary-arterial-hypertension-100647917",false,"NCT07713914","Randomized Study of Triple Therapy vs Sildenafil Dose Optimization in Pulmonary Arterial Hypertension","A Prospective, Randomized, Open-Label Study Comparing Triple Therapy Versus Sildenafil Dose Optimization in Patients With Pulmonary Arterial Hypertension Using COMPERA 2.0 Risk Stratification as the Primary Outcome","ASCEND-PAH","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of pulmonary arterial hypertension (PAH, Group 1) confirmed according to accepted clinical and hemodynamic criteria\n* Stable treatment with an endothelin receptor antagonist in combination with sildenafil prior to randomization\n* Classified as intermediate-low, intermediate-high, or high risk according to the COMPERA 2.0 four-stratum model\n* Clinical indication for therapeutic escalation\n* Availability for follow-up assessment between 3 and 6 months after randomization\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Participation in another interventional clinical trial that mandates treatment modification\n* Known contraindication to prostacyclin pathway agents (including iloprost or selexipag)\n* Known contraindication to sildenafil dose escalation\n* Pregnancy or breastfeeding\n* Women of childbearing potential not using effective contraception\n* Any clinical condition that, in the investigator's judgment, would interfere with study participation or outcome assessment","ALL","18 Years",{"count":77,"type":78},196,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","Pulmonary arterial hypertension (PAH) is a rare and progressive disease characterized by increased pressure in the pulmonary arteries, leading to right heart failure and premature death. Although combination therapy has improved outcomes, many patients remain at intermediate or high clinical risk despite treatment.\n\nWhen patients do not reach low-risk status, treatment escalation is recommended. However, different escalation strategies are used in clinical practice, including increasing the dose of existing medications or adding a third drug that targets a different biological pathway. There is limited prospective randomized evidence directly comparing these approaches.\n\nThe ASCEND-PAH study is a prospective, randomized, open-label clinical trial designed to compare two therapeutic escalation strategies in adults with PAH who remain at intermediate or high risk despite dual therapy with an endothelin receptor antagonist and sildenafil. Participants will be randomized to either: (1) escalation to triple therapy with the addition of a prostacyclin pathway agent, or (2) optimization of dual therapy by increasing the dose of sildenafil.\n\nThe primary objective is to compare the proportion of patients who improve their risk category according to the COMPERA 2.0 four-stratum risk model within 3 to 6 months after randomization. Secondary outcomes include changes in functional status, exercise capacity, biomarkers, clinical worsening, safety, and treatment persistence",[84],"Pulmonary Arterial Hypertension (PAH)",[86,87,88,15,89],"Pulmonary Arterial Hypertension","Therapeutic Escalation","Triple Therapy","Randomized Clinical Trial","2026-07-28",{"date":92,"type":93},"2026-07-30","ACTUAL",{"date":95,"type":78},"2026-07-22",{"date":97,"type":78},"2028-12-31",{"name":5,"class":6},1]