A Study of a Mean Pulmonary Artery Pressure-Targeted Appr... | NCT05203510

Status Module

Name	Class
Lung Biotechnology PBC	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treprostinil	Experimental	Participants will receive parenteral treprostinil at initial dose of 1.25 nanograms/kilogram/minute (at minimum) either intravenously or subcutaneously. Based on mPAP assessments and after a minimum dose of parenteral treprostinil is reached, at Investigator's (PI's) discretion, participants may transition to oral treprostinil and continue dose uptitration for further reduction of mPAP. Based on Month 12 mPAP assessment, participants may transition from parenteral to oral treprostinil at PI's discretion after completion of Month 12 assessment and continue uptitration for further reduction of mPAP. If minimum dose of parenteral treprostinil is not reached at Month 6/12 at PI's discretion, uptitration of parenteral treprostinil or oral treprostinil transition may occur to maintain normal mPAP. Treprostinil therapy (parenteral or oral) may continue as tolerated toward goal of further reduction of mPAP until Month 36.	Drug: Parenteral Treprostinil Drug: Oral Treprostinil

Name	Type	Description	Arm Group Labels	Other Names
Parenteral Treprostinil	Drug	Parenteral treprostinil will be administered per schedule specified in the arm description.	Treprostinil

Outcomes Module

Measure	Description	Time Frame
Change From Baseline in Right Ventricular Ejection Fraction (RVEF), as Measured by Cardiac Magnetic Resonance Imaging (cMRI) at Month 12		Baseline, Month 12

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in mPAP at Month 12		Baseline, Month 12
Number of Participants With Clinical Improvement From Baseline to Month 12, 24, and 36	Clinical improvement is defined as meeting all 3 criteria: - improvement in six-minute walk distance (6MWD) increase ≥10% or ≥30 meters; - improvement in World Health Organization (WHO) functional class (FC) or maintenance of WHO FC I/II; - improvement in N-terminal pro-brain natriuretic peptide (NT-proBNP) decrease ≥30% or <300 ng/liter (L).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed PAH (WHO Group 1) classified by one of the following subgroups:
- Idiopathic, heritable or drug/toxin induced (with the exception of amphetamine-induced PAH)
- Associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥1 year)
- Associated with connective tissue disease
- Associated with human immunodeficiency virus infection
Baseline visit right heart catheterization (RHC) must also meet the following criteria:
- mPAP >35 mmHg
- Pulmonary vascular resistance (PVR) >2 Wood units
- Pulmonary artery wedge pressure (PAWP) ≤15 mmHg
On a stable dose of an endothelin receptor antagonist (ERA) and/or phosphodiesterase type 5 inhibitor (PDE-5i) or soluble guanylate cyclase stimulator (sGC) therapy or if treatment naïve, willing to take one of these medications in addition to study drug
REVEAL Lite 2 risk score ≤9
WHO FC II or III
6MWD >165 meters

Exclusion Criteria:

PAH-related Exclusion Criteria:

Prior or current use of epoprostenol, treprostinil, iloprost, beraprost, or selexipag
Positive vasoreactivity test in idiopathic, heritable, or drug/toxin induced PAH
Amphetamine use within the past 12 months
WHO Groups 2, 3, 4, and 5
Use of any other investigational drug, device, or therapy within 30 days of the Baseline visit
Moderate or severe hepatic impairment (Child-Pugh Class B and C)
Any other clinically significant illness or abnormal laboratory value(s) measured during screening that, in the opinion of the Investigator, might adversely affect interpretation of the study data or participant safety (for example, active infection, chronic thromboembolic pulmonary hypertension, or acute/recent deep vein thrombosis or pulmonary embolism)
Chronic atrial fibrillation, multiple premature ventricular or atrial contractions of clinical significance, or any other condition that would interfere with proper cardiac gating during cMRI
Permanent cardiac pacemaker or automatic internal cardioverter that would interfere with conduct of cMRI
Metallic implant (for example, defibrillator, neurostimulator, hearing aid, permanent infusion device, implantable pump, or body plates/screws/bolts) that would interfere with conduct of cMRI

CardioMEMS-related Exclusion Criteria, if applicable:

Previously implanted with CardioMEMS pulmonary artery Sensor or unwilling/unable to permit collection and perform upload (transmission) of pulmonary artery pressure (PAP) readings
Unable to take dual antiplatelet or anticoagulation therapy for 30 days after CardioMEMS PA Sensor implantation unless the participant has an indication for warfarin or direct oral anticoagulant

NOTE: Other inclusion and exclusion criteria may apply.

Facility	Status	City	State	ZIP	Country	Contacts
Banner University Medical Center (University of Arizona)		Phoenix	Arizona	85006	United States
HonorHealth John C. Lincoln Medical Center