Could a new drug free PAH patients from daily pump therapy?
NCT ID NCT07700303
First seen Jul 14, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This study tests whether people with pulmonary arterial hypertension (PAH) who are doing well on the drug sotatercept can safely stop their background prostacyclin therapy. Prostacyclin drugs can cause side effects and are hard to manage. The trial compares patients who slowly stop prostacyclin therapy with those who continue it, to see if stopping is safe and does not worsen their condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sotatercept
- What this could lead to
- If successful, this could allow some PAH patients to stop troublesome prostacyclin therapies, reducing side effects and simplifying treatment.
- What could go wrong
- This is a small, early-stage study, and stopping background therapy may worsen PAH in some patients. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: In order to be eligible for this study, a participant must meet all of the following criteria: 1. Adults ≥ 18 years old diagnosed with PAH. 2. Treatment with sotatercept for ≥6 months. 3. Background therapy with ≥2 PAH vasodilator therapies, one of which is a parenteral prostacyclin or selexipag. 4. At low or intermediate-low risk, defined using the 2022 ESC/ERS guidelines 4-strata risk assessment tool (Table 1). 5. RHC at screening or historical within 8 weeks of screening, and after at least 6 months of sotatercept treatment, demonstrating a mPAP ≤40 mmHg and PVR ≤5 WU 6. The ability to adhere to the study visit schedule and to comprehend and comply with all protocol requirements. 7. Ability to provide informed consent. Exclusion Criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: 1. Known intolerance to sotatercept 2. A RHC at screening or historical within 8 weeks of screening and after ≥6 months of sotatercept treatment demonstrating mPAP \> 40 mmHg or PVR \> 5 WU. 3. Hospitalization for worsening PAH or right heart failure within the 3 months prior to screening. 4. Active listing for lung or heart/lung transplantation. 5. Metastatic cancer or any other condition with a life expectancy \< 6 months, 6. Female patients who are pregnant or who are of childbearing age and are unwilling to use contraception during the study. 7. History of ≥ 3 interruptions or missed doses of sotatercept for any reason within the previous 6 months prior to screening. 8. Patients who received any investigational medication within 1 month prior to screening (unless known to be placebo) or who are scheduled to receive another investigational drug during the course of this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Alberta Hospital
Edmonton, Alberta, Canada
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