Randomized trial comparing efficacy and safety of initial triple therapy including parenteral treprostinil to initial double oral therapy in PAH group I patients – TripleTRE

Pulmonary arterial hypertension (group I)

(Non-) Response to the assigned treatment: 1. Therapy-responder: achievement of low-risk status between week 24 and week 48 2. Therapy-non-responder: a) PH related deterioration to high-risk status, lung transplantation or death between week 12 and week 48 and/or b) additional medication or change of initial PH specific medication due to unsatisfactory efficacy between week 12 and week 48 and/or c) low risk status not achieved up to week 48 Risk status is assessed with the simplified four-

Change in haemodynamic parameters by means of right heart catheterization (RHC) between baseline and week 24: a. Pulmonary Vascular Resistance (PVR) b. Mean pulmonary arterial pressure (mPAP) c. Mean right atrial pressure (mRAP) d. Right atrial pressure (RAP) e. Cardiac index (CI) f. Cardiac output (CO), Change in right heart structure and function assessed by echocardiography between baseline and week 24: a. RV-PA coupling estimated by the ratio of tricuspid annular plane systolic excursion by pulmonary artery systolic pressure (TAPSE/sPAP) b. RV end-diastolic area (RVEDA) c. RV end-systolic area (RVESA) d. RV fractional area change (RVFAC) e. Right atrium (RA) area f. Pericardial effusion, Time to achievement of low-risk status assessed by the simplified four-strata risk-assessment tool, Rate of change of risk status by means of the simplified four-strata risk-assessment tool, Change in the number of low-risk criteria based on the French PH Network Registry (FPHR) risk assessment tool between baseline and week 24, Change in REVEAL 2.0 risk score between baseline and week 24, Rate of change in WHO FC, Rate of change in 6MWD, Rate of change in NT-proBNP/BNP levels, Change in quality of life by questionnaires emPHasis-10 and EQ-5D-5L, Total number of clinical worsening(s) where clinical worsening is defined as: PAH related death (including all deaths where PAH cannot be excluded as cause) and lung transplantation due to PAH, PH-related hospitalization, Post baseline (screening visit) decrease in 6MWD by 15%, Post baseline (screening visit) worsening of WHO FC, Overall and transplant free survival, Adverse events (AE), Adverse reactions (ADR), Serious Adverse events (SAE), Serious Adverse Drug Reactions (SADR), Suspected unexpected serious adverse reactions (SUSAR)

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