Treprostinil Therapy to Reverse Right Ventricular Remodeling in Pulmonary Arterial Hypertension

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)
Show more

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

Study Details
Disease Type/Condition

Other

Principal Investigator

Geft, Dael

Age Group

Adult

Phase

IV

IRB Number

STUDY00001831

ClinicalTrials.gov ID

NCT05203510

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Geft, Dael

Age Group

Adult

Phase

IV

IRB Number

REM-PH-418

ClinicalTrials.gov ID

NCT05203510

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org