The effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment. conditions: Pulmonary Arterial Hypertension studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, two-arm, open-label, low-interventional, phase IV, multi-centre clinical trial comparing efficacy and safety of initial triple therapy including parenteral treprostinil to initial double oral therapy (background therapy with endothelin receptor antagonist - ERA and phosphodiesterase type-5 inhibitor - PDE-5i) by proportion of patients achieving low risk status according to the simplified four-strata risk-assessment tool from week 24 up to 48 weeks in 110 (55/group) treatment-naïve adult intermediate-high risk or intermediate-low risk patients with severe hemodynamic impairment with pulmonary arterial hypertension (PAH) (group I). primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: Generic treprostinil sodium + Standard of Care (Double Oral) name: Standard of Care - Double Oral measure: Patients achieving (non-)response status to the assigned treatment in terms of achievement of low-risk status measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - PVR measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - mPAP measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - mRAP measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - CI measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - CO measure: Change in hemodynamic parameters by means of right heart catheterization (RHC) - RAP measure: Change in right heart structure and function assessed by echocardiography - TAPSE/sPAP measure: Change in right heart structure and function assessed by echocardiography - RVEDA measure: Change in right heart structure and function assessed by echocardiography - RVESA measure: Change in right heart structure and function assessed by echocardiography - RVFAC measure: Change in right heart structure and function assessed by echocardiography - RA measure: Change in right heart structure and function assessed by echocardiography - Pericardial effusion measure: Time to achievement of low-risk status measure: Rate of change of risk status measure: Change in the number of low-risk criteria based on the French PH Network Registry (FPHR) risk assessment tool measure: Change in REVEAL 2.0 risk score measure: Rate of change in WHO-FC measure: Rate of change in 6MWD measure: Rate of change in NT-proBNP/BNP levels measure: Total number of clinical worsening(s) measure: Overall and transplant free survival measure: Rate of change in quality of life - emPHasis-10 measure: Rate of change in quality of life - EQ-5D-5L measure: Safety outcomes: sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ordensklinikum Linz status: RECRUITING city: Linz country: Austria name: Regina Steringer-Mascherbauer role: CONTACT phone: +437327676 phoneExt: 4916 email: regina.steringer-mascherbauer@ordensklinikum.at name: Regina Steringer-Mascherbauer role: PRINCIPAL_INVESTIGATOR lat: 48.30639 lon: 14.28611 facility: Medical University Vienna status: RECRUITING city: Vienna country: Austria name: Irene Lang role: CONTACT phone: +43140400 phoneExt: 4623 email: irene.lang@meduniwien.ac.at name: Irene Lang role: PRINCIPAL_INVESTIGATOR lat: 48.20849 lon: 16.37208 facility: Fakultní Nemocnice Olomouc status: NOT_YET_RECRUITING city: Olomouc country: Czechia name: Jan Přeček role: CONTACT phone: +420588445102 email: jan.precek@fnol.cz name: Jan Přeček role: PRINCIPAL_INVESTIGATOR lat: 49.59552 lon: 17.25175 facility: Všeobecná fakultní nemocnice v Praze status: NOT_YET_RECRUITING city: Praha country: Czechia name: Pavel Jansa role: CONTACT phone: +420224962629 email: pavel.jansa@vfn.cz name: Pavel Jansa role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 facility: Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris status: NOT_YET_RECRUITING city: Paris country: France name: Olivier Sitbon role: CONTACT phone: +33145217883 email: olivier.sitbon@abc.aphp.fr name: Olivier Sitbon role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpitaux Universitaires de Strasbourg status: NOT_YET_RECRUITING city: Strasbourg country: France name: Marianne Riou role: CONTACT phone: +330369550686 email: marianne.riou@chru-strasbourg.fr name: Marianne Riou role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: DRK Kliniken Berlin Westend status: NOT_YET_RECRUITING city: Berlin country: Germany name: Christian Opitz role: CONTACT phone: +493030354815 email: c.opitz@drk-kliniken-berlin.de name: Christian Opitz role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: University Hospital Carl Gustav Carus of Technical University Dresden status: NOT_YET_RECRUITING city: Dresden country: Germany name: Michael Halank role: CONTACT phone: +4935145813981 email: michael.halank@uniklinikum-dresden.de name: Michael Halank role: PRINCIPAL_INVESTIGATOR lat: 51.05089 lon: 13.73832 facility: Universitätsmedizin Greifswald status: NOT_YET_RECRUITING city: Greifswald country: Germany name: Ralf Ewert role: CONTACT phone: +4938348680500 email: ewert@uni-greifswald.de name: Ralf Ewert role: PRINCIPAL_INVESTIGATOR lat: 54.09311 lon: 13.38786 facility: Gottsegen National Cardiovascular lnstitute status: NOT_YET_RECRUITING city: Budapest country: Hungary name: Olga Hajnalka Balint role: CONTACT phone: +3612152139 email: titkarsag@kardio.hu name: Olga Hajnalka Balint role: PRINCIPAL_INVESTIGATOR lat: 47.49801 lon: 19.03991 facility: Medical University of Szeged status: NOT_YET_RECRUITING city: Szeged country: Hungary name: Gergely Ágoston role: CONTACT phone: +3662545553 email: agoston.gergely@med.u-szeged.hu name: Gergely Ágoston role: PRINCIPAL_INVESTIGATOR lat: 46.253 lon: 20.14824 facility: Sapienza University of Rome status: RECRUITING city: Rome country: Italy name: Roberto Badagliacca role: CONTACT phone: +39064402727 email: roberto.badagliacca@uniroma1.it name: Roberto Badagliacca role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: John Paul II Hospital Krakow status: NOT_YET_RECRUITING city: Kraków country: Poland name: Grzegorz Kopeć role: CONTACT phone: +48126143399 name: Grzegorz Kopeć role: PRINCIPAL_INVESTIGATOR lat: 50.06143 lon: 19.93658 facility: Fryderyk Chopin Hospital in European Health Centre Otwock status: NOT_YET_RECRUITING city: Otwock country: Poland name: Marcin Kurzyna role: CONTACT phone: +48227103052 email: marcin.kurzyna@ecz-otwock.pl name: Marcin Kurzyna role: PRINCIPAL_INVESTIGATOR lat: 52.10577 lon: 21.26129 facility: Centro Hospitalar Lisboa Norte - Santa Maria University Hospital status: NOT_YET_RECRUITING city: Lisboa country: Portugal name: Rui Miguel Freire Plácido role: CONTACT phone: +351217805306 email: rui.placido@chln.min-saude.pt name: Rui Miguel Freire Plácido role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 facility: Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu status: NOT_YET_RECRUITING city: Bucharest country: Romania name: Ioan Mircea Coman role: CONTACT phone: +40213175222 name: Ioan Mircea Coman role: PRINCIPAL_INVESTIGATOR lat: 44.43225 lon: 26.10626 facility: Emergency Clinical County Hospital of Targu Mures status: NOT_YET_RECRUITING city: Târgu-Mureş country: Romania name: Ioan Tilea role: CONTACT phone: +40265215551 email: ioan.tilea@umfst.ro name: Ioan Tilea role: PRINCIPAL_INVESTIGATOR lat: 46.54245 lon: 24.55747 facility: Hospital Clinic of Barcelona status: NOT_YET_RECRUITING city: Barcelona country: Spain name: Isabel Blanco Vich role: CONTACT phone: +34932275779 email: iblanco2@clinic.cat name: Isabel Blanco Vich role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Ramon y Cajal status: NOT_YET_RECRUITING city: Madrid country: Spain name: Jose Andres Tenes Mayen role: CONTACT phone: +34913368263 email: jtenes@salud.madrid.org name: Jose Andres Tenes Mayen role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False