Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
United Therapeutics
With
Lung Biotechnology PBC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
