Status:
RECRUITING
Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension
Lead Sponsor:
University of Florida
Collaborating Sponsors:
United Therapeutics
Conditions:
Sarcoidosis
Precapillary Pulmonary Hypertension
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with sarcoidosis-associated interstitial lung disease and pulmonary hypertension.
Detailed Description
Pulmonary sarcoidosis-associated pulmonary hypertension is classified as WHO Group 5 pulmonary hypertension and may occur in anywhere from 5-20% of sarcoidosis patients. Inhaled treprostinil has shown...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Patient on any prostanoid or prostanoid analog therapy
- Patients with left sided heart disease as defined by either a PCWP \> 15 mmHg and/or left ventricular ejection fraction \< 40%
- Use of any investigational drug/device, or participation in any investigational study with therapeutic intent within 30 days prior to randomization.
Key Trial Info
Start Date :
January 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 29 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03814317
Start Date
January 30 2020
End Date
July 29 2026
Last Update
June 30 2025
Active Locations (1)
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1
University of Florida, Division of Pulmonary and Critical Care Medicine
Gainesville, Florida, United States, 32610