A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension
- Conditions
- Pulmonary Arterial Hypertension
- Registration Number
- NCT05203510
- Lead Sponsor
- United Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Confirmed PAH (WHO Group 1) classified by one of the following subgroups:<br><br> - Idiopathic, heritable or drug/toxin induced (with the exception of<br> amphetamine-induced PAH)<br><br> - Associated with repaired congenital systemic-to-pulmonary shunts (repaired =1<br> year)<br><br> - Associated with connective tissue disease<br><br> - Associated with human immunodeficiency virus infection<br><br> - Baseline visit right heart catheterization (RHC) must also meet the following<br> criteria:<br><br> - mPAP >35 mmHg<br><br> - Pulmonary vascular resistance (PVR) >2 Wood units<br><br> - Pulmonary artery wedge pressure (PAWP) =15 mmHg<br><br> - On a stable dose of an endothelin receptor antagonist (ERA) and/or phosphodiesterase<br> type 5 inhibitor (PDE-5i) or soluble guanylate cyclase stimulator (sGC) therapy or<br> if treatment naïve, willing to take one of these medications in addition to study<br> drug<br><br> - REVEAL Lite 2 risk score =9<br><br> - WHO FC II or III<br><br> - 6MWD >165 meters<br><br>Exclusion Criteria:<br><br>PAH-related Exclusion Criteria:<br><br> - Prior or current use of epoprostenol, treprostinil, iloprost, beraprost, or<br> selexipag<br><br> - Positive vasoreactivity test in idiopathic, heritable, or drug/toxin induced PAH<br><br> - Amphetamine use within the past 12 months<br><br> - WHO Groups 2, 3, 4, and 5<br><br> - Use of any other investigational drug, device, or therapy within 30 days of the<br> Baseline visit<br><br> - Moderate or severe hepatic impairment (Child-Pugh Class B and C)<br><br> - Any other clinically significant illness or abnormal laboratory value(s) measured<br> during screening that, in the opinion of the Investigator, might adversely affect<br> interpretation of the study data or participant safety (for example, active<br> infection, chronic thromboembolic pulmonary hypertension, or acute/recent deep vein<br> thrombosis or pulmonary embolism)<br><br> - Chronic atrial fibrillation, multiple premature ventricular or atrial contractions<br> of clinical significance, or any other condition that would interfere with proper<br> cardiac gating during cMRI<br><br> - Permanent cardiac pacemaker or automatic internal cardioverter that would interfere<br> with conduct of cMRI<br><br> - Metallic implant (for example, defibrillator, neurostimulator, hearing aid,<br> permanent infusion device, implantable pump, or body plates/screws/bolts) that would<br> interfere with conduct of cMRI<br><br>CardioMEMS-related Exclusion Criteria, if applicable:<br><br> - Previously implanted with CardioMEMS pulmonary artery Sensor or unwilling/unable to<br> permit collection and perform upload (transmission) of pulmonary artery pressure<br> (PAP) readings<br><br> - Unable to take dual antiplatelet or anticoagulation therapy for 30 days after<br> CardioMEMS PA Sensor implantation unless the participant has an indication for<br> warfarin or direct oral anticoagulant<br><br>NOTE: Other inclusion and exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline in Right Ventricular Ejection Fraction (RVEF), as Measured by Cardiac Magnetic Resonance Imaging (cMRI) at Month 12
- Secondary Outcome Measures
Name Time Method