Pulmonary Arterial HypertensionEVOLVENCT05060315
Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin
An observational study of Pulmonary Arterial Hypertension, run by United Therapeutics at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Remunity Pump for Remodulin
- Type of treatment
- Injection or infusion
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 60 participants in the United States will be enrolled in this study. Participants new to parenteral prostacyclin-class therapy prior to initiating next generation pump for Remodulin will be enrolled in the De Novo Cohort. Participants that had received SC treprostinil therapy via a previous generation infusion pump prior to transitioning to delivery of SC Remodulin via a next generation infusion pump will be enrolled in the Transition Cohort. The number of participants in each cohort will be assessed throughout the duration of study and may be refined accordingly.
Who may be able to join
- The patient is greater than 22 years of age at time of providing informed consent.
- The patient is willing and able to provide informed consent and has the ability to answer surveys, questionnaires, and use the diary in English.
- The patient has started SC Remodulin via the Remunity Pump for Remodulin (treprostinil) Injection prior to providing informed consent.
- 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.
- The patient is greater than 22 years of age at time of providing informed consent.
- The patient is willing and able to provide informed consent and has the ability to answer surveys, questionnaires, and use the diary in English.
- The patient has started SC Remodulin via the Remunity Pump for Remodulin (treprostinil) Injection prior to providing informed consent.
- 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.
Who cannot join
- The patient is pregnant, trying to become pregnant, or lactating.
- 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.
- 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.
- For those in the Transition Cohort: The patient had been receiving parenteral treprostinil via IV administration prior to transitioning to the Remunity Pump.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
Read the detailed description
This is a virtual, patient-centric, observational study that will follow approximately 60 participants through 8 weeks following initiation of Remodulin therapy via their UTC-developed next generation infusion pump and consists of remote and electronic assessments administered to patient via the uMotif® data capture platform at Study Enrollment, Week 2, Week 4, and Week 8 or Early Withdrawal (if applicable).
The study population will consist of 2 cohorts of PAH patients:
- De Novo Cohort: patients new to parenteral prostacyclin-class therapy.
- Transition Cohort: patients who had been receiving SC treprostinil therapy via a previous generation infusion pump prior to transitioning to a next generation infusion pump.
The De Novo Cohort will initiate subcutaneous (SC) Remodulin via a next generation infusion pump as prescribed by their healthcare professional. Participants will be followed from day of Study Enrollment, which will be Day 1, through 8 weeks while using next generation infusion pump, or until discontinuation of Remodulin (early withdrawal), whichever comes first.
The Transition Cohort will have previously been receiving SC treprostinil utilizing a previous generation infusion pump prior to transitioning to delivery of Remodulin via next generation infusion pump, as prescribed by their healthcare provider. Participants will be followed from day of Study Enrollment, which will be Day 1, through 8 weeks while using next generation infusion pump, or until discontinuation of Remodulin (early withdrawal), whichever comes first.
Following the completion of study assessments at Week 8 or Early Withdrawal (if applicable), participants will continue Remodulin therapy via their infusion pump at their prescriber's discretion.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Remunity Pump for Remodulin
- Keywords
- PAH
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remunity Pump for RemodulinCombination product
Participants on the study will receive Remodulin via the Remunity Pump with dosing and titration managed at the discretion of the prescribing healthcare professional. Dosing and titration of Remodulin will in no way be influenced by the participation in this study or this protocol.
| Study group | Role | What they receive |
|---|---|---|
| De Novo Cohort | Patients new to parenteral prostacyclin-class therapy. Receives: Combination Product: Remunity Pump for Remodulin | |
| Transition Cohort | Patients who had been receiving SC treprostinil therapy via a previous generation infusion pump prior to transitioning to a next generation infusion pump. Receives: Combination Product: Remunity Pump for Remodulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe and assess time spent on drug administration activities related to the United Therapeutics Corp.-developed next generation pumps to administer Remodulin in patients with PAH
Participants will be asked to participate in a comprehensive collection of the drug administration activities data consisting of a 7-day evaluation period of daily drug administration activities pertaining to their next generation infusion pump via the Drug Administration Activities Diary.
Measured: 8 Weeks
To observe and assess patient reported outcomes via the Pulmonary Hypertension Functional Class Self-Report
Participant self-assessment of Functional Class (I to IV) will be performed using the Pulmonary Hypertension Functional Class Self-Report (PH-FC-SR), as adapted from the pulmonary hypertension World Health Organization Functional Classification System.
Measured: 8 Weeks
To observe and assess patient reported outcomes via the Patient Perception of Parenteral Infusion System Questionnaire
The Patient Perception of Parenteral Infusion System Questionnaire will be administered to assess the participant's perception of their infusion pumps.
Measured: 8 Weeks
To observe and assess patient reported outcomes via the Abbreviated Treatment Satisfaction Questionnaire for Medication
The Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a validated instrument to assess participants' satisfaction with medication, providing scores on 3 scales - effectiveness, convenience, and global satisfaction.
Measured: 8 Weeks
To observe and assess patient reported outcomes via the emPHasis-10 questionnaire
The emPHasis-10 questionnaire is a reliable and validated tool for assessment of health-related quality of life in pulmonary hypertension. It consists of 10 items, which address breathlessness, fatigue, control, and confidence.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start5 Jul 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060315
- Sponsor's protocol ID
- REM-PH-417
- Acronym
- EVOLVE
- Status last verified
- Jan 2025
- First submitted
- 6 Apr 2021
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05060315
- Acronym / sponsor ID
- EVOLVE / REM-PH-417
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 9 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a virtual, patient-centric, observational study that will follow approximately 60 participants through 8 weeks following initiation of Remodulin therapy via their UTC-developed next generation infusion pump and consists of remote and electronic assessments administered to patient via the uMotif® data capture platform at Study Enrollment, Week 2, Week 4, and Week 8 or Early Withdrawal (if applicable).
The study population will consist of 2 cohorts of PAH patients:
- De Novo Cohort: patients new to parenteral prostacyclin-class therapy.
- Transition Cohort: patients who had been receiving SC treprostinil therapy via a previous generation infusion pump prior to transitioning to a next generation infusion pump.
The De Novo Cohort will initiate subcutaneous (SC) Remodulin via a next generation infusion pump as prescribed by their healthcare professional. Participants will be followed from day of Study Enrollment, which will be Day 1, through 8 weeks while using next generation infusion pump, or until discontinuation of Remodulin (early withdrawal), whichever comes first.
The Transition Cohort will have previously been receiving SC treprostinil utilizing a previous generation infusion pump prior to transitioning to delivery of Remodulin via next generation infusion pump, as prescribed by their healthcare provider. Participants will be followed from day of Study Enrollment, which will be Day 1, through 8 weeks while using next generation infusion pump, or until discontinuation of Remodulin (early withdrawal), whichever comes first.
Following the completion of study assessments at Week 8 or Early Withdrawal (if applicable), participants will continue Remodulin therapy via their infusion pump at their prescriber's discretion.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De Novo Cohort | – | Combination Product: Remunity Pump for RemodulinPatients new to parenteral prostacyclin-class therapy. |
| Transition Cohort | – | Combination Product: Remunity Pump for RemodulinPatients who had been receiving SC treprostinil therapy via a previous generation infusion pump prior to transitioning to a next generation infusion pump. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 60 participants in the United States will be enrolled in this study. Participants new to parenteral prostacyclin-class therapy prior to initiating next generation pump for Remodulin will be enrolled in the De Novo Cohort. Participants that had received SC treprostinil therapy via a previous generation infusion pump prior to transitioning to delivery of SC Remodulin via a next generation infusion pump will be enrolled in the Transition Cohort. The number of participants in each cohort will be assessed throughout the duration of study and may be refined accordingly.
Key inclusion criteria (8 listed)
- The patient is greater than 22 years of age at time of providing informed consent.
- The patient is willing and able to provide informed consent and has the ability to answer surveys, questionnaires, and use the diary in English.
- The patient has started SC Remodulin via the Remunity Pump for Remodulin (treprostinil) Injection prior to providing informed consent.
- 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.
- The patient is greater than 22 years of age at time of providing informed consent.
Key exclusion criteria (4 listed)
- The patient is pregnant, trying to become pregnant, or lactating.
- 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.
- 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.
- For those in the Transition Cohort: The patient had been receiving parenteral treprostinil via IV administration prior to transitioning to the Remunity Pump.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remunity Pump for RemodulinParticipants on the study will receive Remodulin via the Remunity Pump with dosing and titration managed at the discretion of the prescribing healthcare professional. Dosing and titration of Remodulin will in no way be influenced by the participation in this study or this protocol. | Combination product | De Novo Cohort, Transition Cohort |
Primary outcome
To observe and assess time spent on drug administration activities related to the United Therapeutics Corp.-developed next generation pumps to administer Remodulin in patients with PAH
Time frame: 8 Weeks
Participants will be asked to participate in a comprehensive collection of the drug administration activities data consisting of a 7-day evaluation period of daily drug administration activities pertaining to their next generation infusion pump via the Drug Administration Activities Diary.
To observe and assess patient reported outcomes via the Pulmonary Hypertension Functional Class Self-Report
Time frame: 8 Weeks
Participant self-assessment of Functional Class (I to IV) will be performed using the Pulmonary Hypertension Functional Class Self-Report (PH-FC-SR), as adapted from the pulmonary hypertension World Health Organization Functional Classification System.
To observe and assess patient reported outcomes via the Patient Perception of Parenteral Infusion System Questionnaire
Time frame: 8 Weeks
The Patient Perception of Parenteral Infusion System Questionnaire will be administered to assess the participant's perception of their infusion pumps.
To observe and assess patient reported outcomes via the Abbreviated Treatment Satisfaction Questionnaire for Medication
Time frame: 8 Weeks
The Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a validated instrument to assess participants' satisfaction with medication, providing scores on 3 scales - effectiveness, convenience, and global satisfaction.
To observe and assess patient reported outcomes via the emPHasis-10 questionnaire
Time frame: 8 Weeks
The emPHasis-10 questionnaire is a reliable and validated tool for assessment of health-related quality of life in pulmonary hypertension. It consists of 10 items, which address breathlessness, fatigue, control, and confidence.
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by United Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe and assess time spent on drug administration activities related to the United Therapeutics Corp.-developed next generation pumps to administer Remodulin in patients with PAH (time frame: 8 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.