RECRUITING

Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension

Conditions

Sarcoidosis Precapillary Pulmonary Hypertension Interstitial Lung Disease right heart catheterization (RHC)pulmonary vascular resistance (PVR)mean pulmonary arterial pressure (mPAP)pulmonary hypertension (PH)Inhaled treprostinil

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with sarcoidosis-associated interstitial lung disease and pulmonary hypertension.

Official Title

An Open-Label Study of Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension and Interstitial Lung Disease (SAPPHIRE)

Quick Facts

Study Start:2020-01-30

Study Completion:2025-07-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03814317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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.

Inclusion Criteria

Exclusion Criteria

* 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

* 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.

Contacts and Locations

Study Contact

Christina M Eagan, DNP

CONTACT

352-273-8990

christina.eagan@medicine.ufl.edu

Ali Ataya, RN

CONTACT

352-273-8740

ali.ataya@medicine.ufl.edu

Principal Investigator

Ali Ataya, MD

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

University of Florida, Division of Pulmonary and Critical Care Medicine

Gainesville, Florida, 32610

United States

Collaborators and Investigators

Sponsor: University of Florida

Ali Ataya, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-30

Study Completion Date2025-07-29

Study Record Updates

Study Start Date2020-01-30

Study Completion Date2025-07-29

Terms related to this study

Keywords Provided by Researchers

right heart catheterization (RHC)
pulmonary vascular resistance (PVR)
mean pulmonary arterial pressure (mPAP)
pulmonary hypertension (PH)
Inhaled treprostinil
Sarcoidosis

Additional Relevant MeSH Terms

Sarcoidosis
Precapillary Pulmonary Hypertension
Interstitial Lung Disease