Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension

Korábbi kezelés

• Patient on any prostanoid or prostanoid analog therapy
• Use of any investigational drug/device, or participation in any investigational study with therapeutic intent within 30 days prior to randomization.

Laborértékek

• Patients with left sided heart disease as defined by either a PCWP > 15 mmHg and/or left ventricular ejection fraction < 40%

Egyéb

• Pregnant patients or those who are actively lactating
• Patient not willing to use form of birth control (if applicable) during the study
• Inability to undergo 6MWT, RHC, PFTs or CMRI
• Predicted survival < 6 months

• Study participant willing and able to provide informed consent
• Negative urine pregnancy test at baseline for females of childbearing potential
• Established diagnosis of sarcoidosis by ATS/ERS/WASOG 1999 Statement on of Sarcoidosis
• Presence of interstitial lung disease by Scadding Stage IV chest radiograph or extensive fibrosis on chest computed tomography
• Right heart catheterization within six months of baseline visit showing precapillary pulmonary hypertension (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg, and PVR > 3 WU)
• Patient on stable sarcoidosis therapy for at least three months prior to screening
• If patients are on oral PAH therapy (PDE5i/SCGS and/or ERA) then dose should be stable for at least three months prior to screening
• A 6MWT within three months of screening visit of > 100 meters