3. Background therapy with ≥2 PAH vasodilator therapies, one of which is a parenteral prostacyclin or selexipag.
4. At low or intermediate-low risk, defined using the 2022 ESC/ERS guidelines 4-strata risk assessment tool (Table 1).
5. RHC at screening or historical within 8 weeks of screening, and after at least 6 months of sotatercept treatment, demonstrating a mPAP ≤40 mmHg and PVR ≤5 WU
6. The ability to adhere to the study visit schedule and to comprehend and comply with all protocol requirements.
7. Ability to provide informed consent.
You may not be if
1. Known intolerance to sotatercept
2. A RHC at screening or historical within 8 weeks of screening and after ≥6 months of sotatercept treatment demonstrating mPAP \> 40 mmHg or PVR \> 5 WU.
3. Hospitalization for worsening PAH or right heart failure within the 3 months prior to screening.
4. Active listing for lung or heart/lung transplantation.
5. Metastatic cancer or any other condition with a life expectancy \< 6 months,
6. Female patients who are pregnant or who are of childbearing age and are unwilling to use contraception during the study.
7. History of ≥ 3 interruptions or missed doses of sotatercept for any reason within the previous 6 months prior to screening.
8. Patients who received any investigational medication within 1 month prior to screening (unless known to be placebo) or who are scheduled to receive another investigational drug during the course of this study.
Clareo Health | Withdrawal of Prostacyclin Pathway Therapy in Patients With Pulmonary Arterial Hypertension Receiving Sotatercept (WATERLOO)
