PVDOMICS Protocol

Protocol version 1.3 – April 16, 2021

Clarification of Comparator WSPH Group 1 definition:

· mPAP < 25 mmHg (including borderline PH: mPAP 21 to < 25mmHg)

· mPAP >= 25 mmHg, PVR < 3 WU

· Exercise-induced (ePAH) with normal resting hemodynamics and exercise mPAP > 30mmHg, flow (Q) < 10 L/min and mPAP-Q slope > 3 (mmHg/min/L)

· Super-responders with MPAP < mmHg after treatment remain in the WSPH Group 1.

Protocol version 1.2 – June 16, 2017

Protocol version 1.1 – May 12, 2016

Protocol version 1.0 – March 30, 2016