What is the Purpose of this Study?
The purpose of this study is to evaluate whether giving a drug called treprostinil earlier in a patient’s pulmonary arterial hypertension (PAH) diagnosis and then quickly increasing the dose will improve the patient’s PAH symptoms and function of the right ventricle (a chamber of the heart), as well as reverse right ventricular remodeling (changes in heart size and shape due to PAH). Two types of treprostinil will be used in this study: parenteral treprostinil and oral treprostinil. Both parenteral and oral treprostinil are approved by the U.S. Food and Drug Administration (FDA) for the treatment of PAH.
Study procedures include completing quality of life questionnaires, physical exams, blood draws, electrocardiograms, cardiac magnetic resonance imaging, echocardiograms, 6-minute walk tests, and right heart catheterization (RHC, a procedure to measure heart pressure). A device called the CardioMEMS PA Sensor will be permanently implanted in the pulmonary artery during the RHC procedure. This device is approved by the U.S. Food and Drug Administration (FDA) for heart failure, but its use in PAH is investigational.
Eligibility
- * 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)
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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:
- * 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
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 4, Prospective, Multicenter, Single-Arm Study of a Mean Pulmonary Artery Pressure-Targeted Approach with Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Patients with Pulmonary Arterial Hypertension: ARTISAN