IMPACT-CTEPH Initial dual oral coMbination therapy versus standard-of-care initial oral monotherapy Prior to balloon pulmonary Angioplasty in patients with inoperable Chronic thromboembolic pulmonary hyperTension”

Inoperable Chronic thromboembolic pulmonary hyperTension, Pneumology

Pulmonary vascular resistance (PVR) at rest at week 16 expressed as a percentage of the baseline resting PVR.

Change from baseline to week 16 in : - 6-min walk distance (6MWD) - World Health Organisation (WHO) functional class (FC) and Borg dyspnea score - N-terminal pro-brain natriuretic peptide (NT-proBNP) level - Quality of life EQ-5D-3L scale., Change from baseline to week 42 in : - 6MWD - WHO FC and Borg dyspnea score - NT proBNP level - Quality of life EQ-5D-3L scale., Change from baseline to week 42 in PVR., Percentage of subjects reaching PVR<240 dyn.sec.cm-5 at week 42., Frequency and type of BPA procedure-related complications from BPA procedure to end-of-study., Time from randomization to the first PH-related disease progression event up to end-of-study, defined as any of the following : - Death (all causes) - Need for lung transplantation - Hospitalization due to PH - Initiation of parenteral prostanoid therapy due to PH-related disease progression - Clinical worsening defined as a post-baseline decrease in 6MWD by ≥ 15 % combined with WHO FC III or IV)., Change from baseline to week 29 in : - 6MWD - WHO FC and Borg dyspnea score - NT proBNP level - Quality of life EQ-5D-3L scale.

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