COMMODITIES : Comparison of initial dual oral COMbination therapy to MOnotherapy in pulmonary arterial hypertension with cardiovascular comorbiDITIES

Pulmonary arterial hypertension

Proportion of patients with PAH and cardiovascular comorbidities who achieve after 6 months a low- or an intermediate-low risk profile according to the non-invasive 4-risk strata method as proposed by the 2022 European pulmonary hypertension guidelines.

• Change in pulmonary vascular resistance, • Percent change in BNP or NT-proBNP, • Change in 6-minute walk distance, • Proportion of participants who improve in WHO/NYHA FC at the end of the DBPC Treatment Period, • Change in the TAPSE/systolic pulmonary artery pressure (SPAP) ratio, • Rate of Death or Nonfatal Clinical Worsening defined by hospitalisation for PAH worsening or disease progression defined by worsening of functional class and decrease in 6-min walk distance of more than 15% from baseline, or need for additional specific therapy or lung transplantation., • Change in the emPHasis10 score, • Change in the EuroQoL-5 dimensions scale 5 levels (EQ-5D-5L), • All causes of death, • Change in other hemodynamic parameters, • Change in other echocardiographic parameters, • Change of WHO/NYHA functional class, • Rate of death due to PAH, • Treatment-emergent adverse events (AEs), • Treatment-emergent serious AEs (SAES), • Treatment-emergent deaths, • AEs leading to premature discontinuation of study drug, • Change in laboratory variables, • Change in weight and vital signs (arterial blood pressure, heart rate).

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