[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502681":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":46,"centralContacts":51,"locations":57,"responsibleParty":74,"collaborators":76,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":41,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":60,"whyStopped":41,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Sheffield Teaching Hospitals NHS Foundation Trust","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (selexipag\u002Friociguat)","ACTIVE_COMPARATOR","Baseline - established PDE\u002FERA therapy Week 1 - initiate OPA (PDE\u002FERA\u002FOPA therapy) Weeks 2-12 - uptitration of OPA to maximal therapy (PDE\u002FERA\u002FOPA therapy) Weeks 13-14 - reduce OPA (PDE\u002FERA\u002FOPA therapy) Week 15 - washout OPA (PDE\u002FOPA therapy) Week 16 - washout PDE (ERA therapy) Week 17 - initiate sGCS (ERA\u002FsGCS therapy) Weeks 18-27 - uptitration of sGCS to maximal therapy (ERA\u002FsGCS therapy)",[13,14,15,16],"Drug: Selexipag","Drug: Riociguat","Device: CardioMEMS pulmonary artery pressure monitor","Device: Confirm Rx",{"label":18,"type":10,"description":19,"interventionNames":20},"Arm B (riociguat\u002Fselexipag)","Baseline - established PDE\u002FERA therapy Week 1 - washout PDE (ERA therapy only) Week 2 - initiate sGCS (ERA\u002FsGCS therapy) Weeks 3-12 - uptitration of sGCS to maximal therapy (ERA\u002FsGCS therapy) Week 13 - reduce sGCS (ERA\u002FsGCS therapy) Week 14 - reduce and washout sGCS (ERA therapy) Week 15 - initiate PDE (PDE\u002FERA therapy) Week 16 - initiate OPA (PDE\u002FERA\u002FOPA therapy) Weeks 17-27 - uptitration of OPA to maximal therapy (PDE\u002FERA\u002FOPA therapy)",[13,14,15,16],[22,30,36,42],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Selexipag","If Arm A - Up-titration to maximum tolerated dose followed by de-escalation If Arm B - Up-titration to maximum tolerated dose followed by observation, modification or transition at discretion of responsible care team where necessary.",[9,18],[28,29],"Uptravi","oral prostacyclin IP receptor agonist (OPA)",{"type":23,"name":31,"description":25,"armGroupLabels":32,"otherNames":33},"Riociguat",[9,18],[34,35],"Adempas","soluble guanylate cyclase stimulator (sGCS)",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DEVICE","CardioMEMS pulmonary artery pressure monitor","Implantation and remote monitoring established with patient initiated daily readings",[9,18],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":41},"Confirm Rx","Implantation and remote monitoring established with automated daily readings \u002F downloads",[9,18],[47],{"name":48,"affiliation":49,"role":50},"Alexander Rothman, MD \u002F PhD","University of Sheffield","PRINCIPAL_INVESTIGATOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":41,"email":56},"Shravya Rao","CONTACT","+44 (0) 114 2159550","s.rao@sheffield.ac.uk",[58],{"facility":59,"status":60,"city":61,"state":41,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Sheffield Teaching Hospitals NHS FT","RECRUITING","Sheffield","S10 2JF","United Kingdom","UK",{"type":66,"coordinates":67},"Point",[68,69],-1.4659,53.38297,{"lat":69,"lon":68},[72],{"name":73,"role":54,"phone":41,"phoneExt":41,"email":41},"Alex Rothman",{"type":75,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[77,79,80,82],{"name":78,"class":6},"University of Glasgow",{"name":49,"class":6},{"name":81,"class":6},"University of Newcastle Upon-Tyne",{"name":83,"class":6},"University of Cambridge","100502681","phase-4-pulmonary-hypertension-intensification-and-personalisation-of-combination-rx-100502681",false,"NCT05825417","Pulmonary Hypertension: Intensification and Personalisation of Combination Rx","A Multicentre Randomised Cross-over Trial of Disease Specific Therapy in Patients With Pulmonary Arterial Hypertension (PAH) Implanted With Pulmonary Artery Pressure and Cardiac Rhythm Monitoring Devices (CardioMEMS\u002FConfirmRx)","PHoenix","Inclusion Criteria:\n\n* Able to provide informed consent\n* Age 18-80 years\n* PAH which is idiopathic, heritable or associated with drugs, toxins or connective tissue disease\n* Stable PAH therapeutic regime comprising any combination of ERA and PDE5i for at least 1 month prior to screening (unless unable to tolerate therapy)\n* WHO functional class III\n* Resting mPAP ≥20 mmHg, pulmonary capillary wedge pressure ≤15 mmHg, pulmonary vascular resistance ≥2 Wood Units measured by right heart catheterisation at time of diagnosis\n* 6MWT \\>50m at entry\n* Estimated glomerular filtration rate (eGFR)\\>30 ml\u002Fmin\u002F1.73 m² at entry (Appendix C)\n* Inadequate treatment response (clinically determined)\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Pregnancy\n* Unprovoked pulmonary embolism (at any time)\n* Acute infection at time of screening (rescreening is permitted)\n* PAH due to human immunodeficiency virus, portal hypertension, schistosomiasis, congenital heart disease\n* Pulmonary hypertension due to left heart, lung, thromboembolic or unclear\u002Fmultifactorial disease (Group II-V)\n* Unable to tolerate aspirin or P2Y12 inhibitor\n* Hypersensitivity to selexipag or riociguat\n* Clinically-significant renal disease (eGFR≤30 ml\u002Fmin\u002F1.73m2)\n* Anaemia (haemoglobin \\\u003C10 g\u002Fdl)\n* Left-sided heart disease and\u002For clinically significant cardiac disease, including but not limited to any of the following: aortic or mitral valve disease greater than mild aortic insufficiency; mild aortic stenosis; mild mitral stenosis; or moderate mitral regurgitation","ALL","18 Years","80 Years",{"count":96,"type":97},40,"ESTIMATED","INTERVENTIONAL",[100],"PHASE4","The goal of this clinical trial is to evaluate the capacity of implantable\u002Fremote technology for early evaluation of drug therapies in patients with pulmonary arterial hypertension (PAH). The main question it aims to answer is whether structured changes in clinical therapy will be detectable using implanted regulatory approved devices. Participants will will be implanted with approved medical devices and will enter into a study of approved drugs to assess physiology, activity and patient reported quality-of-life (QoL) outcomes. Researchers will compare two therapeutic strategies in each individual patient to see if the study design provides enough evidence to personalise drug treatment plans",[103],"Pulmonary Arterial Hypertension",[105,106,107],"remote monitoring","therapeutic development","personalised medicine","2026-06-03",{"date":110,"type":111},"2026-06-05","ACTUAL",{"date":113,"type":111},"2023-06-14",{"date":115,"type":97},"2027-01",{"name":5,"class":6},1]