EVOLVE: A Virtual, Observational, Patient-Centric Prospective Study to Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin to Patients With Pulmonary Arterial Hypertension

REM-PH-417

To observe and assess drug administration activities, time spent on drug administration activities, and patient-reported outcomes (PROs) including quality of life, treatment satisfaction, and patient perception of devices related to use of United Therapeutics Corporation (UTC)-developed next-generation infusion pumps to administer Remodulin in patients with Pulmonary Arterial Hypertension (PAH).

2023-07-05

2024-12-31

2024-12-31

Active (not recruiting)

60

Inclusion Criteria - De Novo Cohort: 1. The patient is greater than 22 years of age at time of providing informed consent. 2. The patient is willing and able to provide informed consent and has the ability to answer surveys, questionnaires, and use the diary in English. 3. The patient has started SC Remodulin via the Remunity Pump for Remodulin (treprostinil) Injection prior to providing informed consent. 4. The patient has not been previously treated with a parenteral prostacyclin-class therapy in the past 30 days prior to initiating SC Remodulin therapy with the Remunity Pump, except in cases where the patient initiates inpatient parenteral prostacyclin-class therapy via another infusion pump and subsequently started SC Remodulin therapy with the Remunity Pump for Remodulin (treprostinil) Injection in the outpatient setting. Inclusion Criteria - Transition Cohort: 1. The patient is greater than 22 years of age at time of providing informed consent. 2. The patient is willing and able to provide informed consent and has the ability to answer surveys, questionnaires, and use the diary in English. 3. The patient has started SC Remodulin via the Remunity Pump for Remodulin (treprostinil) Injection prior to providing informed consent. 4. The patient had been receiving continuous infusion of SC treprostinil via an infusion pump other than Remunity for at least 60 days prior to initiating SC Remodulin therapy with the Remunity Pump. Exclusion Criteria: 1. The patient is pregnant, trying to become pregnant, or lactating. 2. For those in the Transition Cohort: The patient has a history of adverse events resulting from interruptions in their treprostinil infusions over relatively short periods (such as less than 8 hours) as they may be at higher risk in the event of pump failure, especially at night. 3. The patient is enrolled in, has participated within the last 30 days, or is planning to participate in an interventional study. Note: co-enrollment in other observational studies is permitted. 4. For those in the Transition Cohort: The patient had been receiving parenteral treprostinil via IV administration prior to transitioning to the Remunity Pump.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-12-18