Why Participate?
Clinical trials can help doctors learn how to prescribe FDA-approved treatments to be as effective as possible for their patients. The purpose of the ARTISAN clinical trial is to determine if administering treprostinil (study drug) early and quickly increasing the dose can improve pulmonary arterial hypertension (PAH). ARTISAN will assess if there are improvements such as reduced PAH symptoms, improved function of the right ventricle (a chamber of the heart), and reversal of changes in the size and shape of the right ventricle due to PAH. By choosing to participate in this study, you may be helping to improve treatment outcomes for others with PAH in the future.
Clinical Trial Description
The ARTISAN clinical trial is a phase 4, multicenter, single-arm study. This means that the study drug has already been approved by the US FDA for treatment of PAH, and investigators are gathering additional information about the drug's effectiveness when it is administered earlier and with faster increase in dose. In single-arm clinical trials, the study drug is not compared to another drug or placebo (inactive drug). This means that every participant enrolled in the trial receives the study drug.
Clinical Trial Design
Participants in the ARTISAN clinical trial will be enrolled for about 37 months (3 years). During this time, participants will take part in three phases of the study, including a 30-day screening period, a 12-month treatment period in which study doctors will evaluate the specific goals of the study, and a 24-month extended treatment period.
The Study Drug
Treprostinil is a form of a chemical compound called prostacyclin. Parenteral (non-oral) treprostinil, Remodulin ® (treprostinil) Injection, is approved to decrease symptoms associated with exercise, and oral treprostinil, Orenitram ® (treprostinil) Extended-release Tablets, is approved to slow disease progression and improve exercise ability in patients with PAH. In this study, both parenteral and oral treprostinil are considered the study drug and will be administered under the supervision of your study doctor. The clinical trial will evaluate if the study drug can potentially improve additional symptoms of PAH.
The Study Device
The CardioMEMS™ HF System is a remote monitoring device used to measure and record the pressure in your pulmonary artery (blood vessel in the lung). It has been approved by the US FDA for heart failure and is currently being evaluated for use in patients with PAH. The CardioMEMSTM HF System has three parts:
- The wireless PA Sensor is a dime-sized permanent implant that measures the pressure in your pulmonary artery. The sensor is placed inside the pulmonary artery by a doctor during a heart catheterization procedure.
- The Patient Electronic System (PES) is a pillow-shaped device with an antenna used to record at-home pulmonary artery pressure measurements. After the sensor is implanted, you will be instructed to use the PES for a few minutes each morning. Readings will automatically be sent for the study team to review in a secure database.
- The Hospital Electronic System is similar to the PES. The study doctor will use this device to measure your pulmonary artery pressure during study visits.
Eligibility Criteria
In order to be eligible for this clinical trial, the participant must provide informed consent and meet the following criteria*:
*Other eligibility (inclusion/exclusion) criteria will apply. For a complete list of trial criteria, please visit: clinicaltrials.gov/ct2/show/NCT05203510.
