Pulmonary Artery HypertensionPhase 4NCT07140484
Sotatercept in Pulmonary Arterial Hypertension
A Phase 4 study testing Sotatercept in people with Pulmonary Artery Hypertension, run by University of Alberta at 1 site in Canada.
Trial summary
The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension. Participants will be asked to: Take Sotatercept every 21 days (±3 days) Each participant will be enrolled in the study for 29 Weeks Visit the clinic 18… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Artery Hypertension
- What is being tested?
- Sotatercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 6 Oct 2025to 1 Jan 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
- Musculoskeletal limitation that precludes participation in cycle ergometry
- Resting oxygen saturation < 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen).
- Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease.
- Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test.
- Baseline platelet count < 50,000/mm3 (< 50.0 × 109/L) in the enrollment period.
Show all 29Show fewer
- Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 mmHg or sitting diastolic blood pressure > 100 mmHg during a screening visit after a period of rest.
- Baseline systolic blood pressure < 90 mmHg at screening.
- Pregnant or breastfeeding women.
- Any of the following clinical laboratory values at the screening visit:
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/m2 (as defined by the Modification of Diet in Renal Disease [MDRD] equation)
- Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels > 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome).
- Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent.
- History of full pneumonectomy.
- Pulmonary function test (PFT) values of forced vital capacity (FVC) < 60% predicted and/or FEV1/FVC < lower limit of normal at the screening visit or within 6 months prior to the screening visit.
- Smoking history of ≥ 20 pack-years or any tobacco smoking or vaping within the previous 3 months.
- Body mass index ≥ 40 kg/m2.
- Planned initiation of an exercise program for cardiopulmonary rehabilitation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).
- Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C).
- History of restrictive, constrictive, or congestive cardiomyopathy.
- History of atrial septostomy within 180 days prior to the screening visit.
- Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) > 500 ms during the Screening Period
- Personal or family history of long QT syndrome (LQTS) or sudden cardiac death.
- Left ventricular ejection fraction < 45% on historical echocardiogram within 6 months prior to the screening visit.
- Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions.
- Cerebrovascular accident within 3 months prior to the Screening Visit.
- Significant mitral or aortic valve dysfunction (greater than moderate mitral regurgitation or aortic regurgitation, or greater than mild mitral stenosis or aortic stenosis).
- Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit.
- Known hypersensitivity to sotatercept or to any ingredient in the formulation or component of the container.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Clinical Physiology Laboratory
Edmonton, Alberta, T6G2R3
Desi Fuhr, 7804921121, fuhr@ualberta.ca
Michael Stickland, 7804923995, michael.stickland@ualberta.ca
About this study
Official title: A Single-arm, Open-label Phase IV Study to Evaluate the Effectiveness of Sotatercept in Improving Pulmonary Vascular Recruitment in Patients With Pulmonary Arterial Hypertension (PAH)
The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension.
Participants will be asked to:
Read more
- Take Sotatercept every 21 days (±3 days)
- Each participant will be enrolled in the study for 29 Weeks
- Visit the clinic 18 times
- Have a physical exam
- Perform assessments of lung function and exercise tests
- Have an ultrasound of their heart
- Have blood draws done at regular intervals
The main objectives of the study are:
Primary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise.
Secondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.
Read the detailed description
Potential participants must provide their written informed consent before any study-specific procedures.
All screening procedures will be completed over two weeks during three separate visits. For participants from the Calgary site (site 2), all Visit 1 procedures except for PFT and CPET may be performed on a separate day in Calgary. Visits 2 and 3 will be performed in Edmonton (site 1). According to patient preference, visits 2 and 3 can be performed on the same day, with a minimum 3-hour break between visits. For participants from Calgary (site 2), the first drug administration will occur in Calgary within seven days of completion of Visit 3 procedures.
Screening will include reviewing the participant's medical, surgical, and family history, collecting demographics, race, and ethnicity, and requesting medical records for relevant external procedures.
Screening procedures include:
Visit 1:
- Informed consent
- Inclusion/exclusion criteria
- Medical history review
- Physical examination
- 12-lead ECG
- Vital signs
- Weight
- WHO FC assessment
- 6MWT
- Pregnancy test
- Hematology (complete blood count)
- Urinalysis
- Hemoglobin
- Serum chemistry
- NT-proBNP
- PFT
- CPET
- QoL assessments
- AE/SAE Review
- Concomitant medication review
Visit 2:
- Hemoglobin
- Rest/exercise DLCO, VC, DM
- Rest/exercise CW-NIRS
- AE/SAE Review
- Concomitant medication review
Visit 3:
- Pregnancy test
- Rest/exercise Echocardiography
- AE/SAE Review
- Concomitant Medication review
- Study drug administration
Measurements/assessments taken during the Screening Period will be recorded as the baseline values for the study assessment of endpoints.
Treatment Period (Visit 4-14) All study procedures should be performed prior to the study drug administration. For participants at the Calgary site, Visits 4,8-14 occur at their home site. For participants from the Calgary site (site 2), Visit 5-7 will be performed in Edmonton (site 1). Visits 5-7 are to be performed before the administration of the 3rd dose of the study drug. According to the patient's preference, visits 6 and 7 may be combined.
Visit 4 (Week 3)
- Focused cardiopulmonary physical examination
- Vital signs
- Weight
- WHO FC assessment
- 6MWT
- Pregnancy test
- Hematology
- Urinalysis
- Clinical worsening assessment
- AE/SAE Review
- Concomitant medication review
Visit 5 (Week 5-6):
- PFT
- CPET
- QoL assessments
- AE/SAE Review
- Concomitant medication review
Visit 6 (Week 5-6):
- Hemoglobin
- Rest/exercise DLCO, VC, DM
- Rest/exercise CW-NIRS
- AE/SAE Review
- Concomitant medication review
Visit 7 (Week 5-6):
- Pregnancy test
- Rest/exercise Echocardiography
- AE/SAE Review
- Concomitant Medication review
Visit 8 (Week 6):
- Focused cardiopulmonary physical examination
- 6MWT
- Vital signs
- Weight
- WHO FC assessment
- Pregnancy test
- Hematology
- Urinalysis
- Clinical worsening assessment
- AE/SAE Review
- Concomitant medication review
Visit 9 (Week 9):
- Focused cardiopulmonary physical examination
- 6MWT
- 12-lead ECG
- Vital signs
- Weight
- WHO FC assessment
- Pregnancy test
- Hematology
- Serum chemistry
- NT-proBNP
- Clinical worsening assessment
- AE/SAE Review
- Concomitant medication review
Visit 10-14 (Week 12 - 24):
- Focused cardiopulmonary physical examination
- 6MWT
- Vital signs
- Weight
- WHO FC assessment
- Pregnancy test
- Hematology
- Urinalysis
- Clinical worsening assessment
- AE/SAE Review
- Concomitant medication review
End-of-Study Period (Visits 13-14) End-of-Study period visits will start 1 week after the last dose of the study medication and will be completed over 2 weeks. Visits 15-17 will be performed in Edmonton (site 1). Visit 16 and 17 can be performed on the same day according to patient preference.
Visit 15:
- Weight
- Hemoglobin
- PFT
- CPET
- QoL Assessment
- AE/SAE Review
- Concomitant medication review
Visit 16:
- Hemoglobin
- Rest/exercise DLCO, VC, DM
- Rest/exercise CW-NIRS
- AE/SAE Review
- Concomitant medication review
Visit 17:
- Rest/exercise echocardiography
- AE/SAE Review
- Concomitant medication review
Follow-up period (Visit 18) A follow-up visit will occur 3 weeks after the last dose of the study medication. For Edmonton participants (site 1), Visit 18 may happen on the same day after Visit 17 is completed.
Visit 18:
- 6MWT
- 12-lead ECG
- Vital signs
- WHO FC assessment
- Pregnancy test
- Hematology
- Urinalysis
- NT-proBNP sample collection
- Clinical worsening assessment
- AE/SAE Review
- Concomitant medication review
Following the last dose of study drug administration, participants have the option to continue with open label sotatercept supplied directly from the manufacturer until either the participant discontinues sotatercept or reimbursement through public or private insurance is in place. The treating physician will be responsible for ongoing monitoring and administration of sotatercept beyond the last dose.
- Conditions
- Pulmonary Artery Hypertension
- Being tested
- Sotatercept
- Keywords
- diffusing capacity, membrane diffusing capacity, pulmonary capillary blood volume
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptDrug
Also called Winrevair
0.7mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Sotatercept Group | Experimental | Sotatercept 0.7mg/kg Receives: Drug: Sotatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung diffusing capacity
Lung diffusing capacity (DLCO) will be measured using six-second, advanced DLCO techniques
Measured: 6 weeks post starting treatment
Lung diffusing capacity
Lung diffusing capacity (DLCO) will be measured using six-second, advanced DLCO techniques
Measured: 23 weeks post starting treatment
Diffusing membrane capacity (Dm)
Diffusing membrane capacity will be measured using six-second, advanced DLCO
Measured: 6 weeks post starting treatment
Diffusing membrane capacity (Dm)
Diffusing membrane capacity will be measured using six-second, advanced DLCO
Measured: 23 weeks post starting treatment
Pulmonary capillary blood volume (Vc)
Pulmonary capillary blood volume (Vc) will be measured using six-second, advanced DLCO techniques
Measured: 6 weeks post starting treatment
Pulmonary capillary blood volume (Vc)
Pulmonary capillary blood volume (Vc) will be measured using six-second, advanced DLCO techniques
Measured: 23 weeks post starting treatment
Secondary outcomes (6)
Cardiac structure and function
Cardiac structure will be measured using standard cardiac ultrasound
Measured: 6 weeks post starting treatment
Cardiac structure and function
Cardiac structure will be measured using standard cardiac ultrasound
Measured: 23 weeks post starting treatment
Cardiac function
Cardiac function will be measured using standard cardiac ultrasound
Measured: 6 weeks post starting treatment
Cardiac function
Cardiac function will be measured using standard cardiac ultrasound
Measured: 23 weeks post starting treatment
Peripheral muscle microcirculation
Peripheral muscle microcirculation will be measured using continuous-wave near-infrared spectroscopy
Measured: 6 weeks post starting treatment
Peripheral muscle microcirculation
Peripheral muscle microcirculation will be measured using continuous-wave near-infrared spectroscopy
Measured: 23 weeks post starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start6 Oct 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Artery HypertensionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Canada Inc., Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Jason Weatherald, MD, Principal investigator, University of AlbertaMichael Stickland, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140484
- Sponsor's protocol ID
- Pro00148970
- Status last verified
- Nov 2026
- First submitted
- 8 Aug 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Phase IV Study to Evaluate the Effectiveness of Sotatercept in Improving Pulmonary Vascular Recruitment in Patients With Pulmonary Arterial Hypertension (PAH)
- ClinicalTrials.gov ID
- NCT07140484
- Acronym / sponsor ID
- Pro00148970
- Conditions
- Pulmonary Artery Hypertension
- Keywords
- diffusing capacity, membrane diffusing capacity, pulmonary capillary blood volume
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Merck Canada Inc., Alberta Health services
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 24 Aug 2025 (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.
The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension.
Participants will be asked to:
- Take Sotatercept every 21 days (±3 days)
- Each participant will be enrolled in the study for 29 Weeks
- Visit the clinic 18 times
- Have a physical exam
- Perform assessments of lung function and exercise tests
- Have an ultrasound of their heart
- Have blood draws done at regular intervals
The main objectives of the study are:
Primary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise.
Secondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.
Detailed description
Potential participants must provide their written informed consent before any study-specific procedures.
All screening procedures will be completed over two weeks during three separate visits. For participants from the Calgary site (site 2), all Visit 1 procedures except for PFT and CPET may be performed on a separate day in Calgary. Visits 2 and 3 will be performed in Edmonton (site 1). According to patient preference, visits 2 and 3 can be performed on the same day, with a minimum 3-hour break between visits. For participants from Calgary (site 2), the first drug administration will occur in Calgary within seven days of completion of Visit 3 procedures.
Screening will include reviewing the participant's medical, surgical, and family history, collecting demographics, race, and ethnicity, and requesting medical records for relevant external procedures.
Screening procedures include:
Visit 1:
- Informed consent
- Inclusion/exclusion criteria
- Medical history review
- Physical examination
- 12-lead ECG
- Vital signs
- Weight
- WHO FC assessment
- 6MWT
- Pregnancy test
- Hematology (complete blood count)
- Urinalysis
- Hemoglobin
- Serum chemistry
- NT-proBNP
- PFT
- CPET
- QoL assessments
- AE/SAE Review
- Concomitant medication review
Visit 2:
- Hemoglobin
- Rest/exercise DLCO, VC, DM
- Rest/exercise CW-NIRS
- AE/SAE Review
- Concomitant medication review
Visit 3:
- Pregnancy test
- Rest/exercise Echocardiography
- AE/SAE Review
- Concomitant Medication review
- Study drug administration
Measurements/assessments taken during the Screening Period will be recorded as the baseline values for the study assessment of endpoints.
Treatment Period (Visit 4-14) All study procedures should be performed prior to the study drug administration. For participants at the Calgary site, Visits 4,8-14 occur at their home site. For participants from the Calgary site (site 2), Visit 5-7 will be performed in Edmonton (site 1). Visits 5-7 are to be performed before the administration of the 3rd dose of the study drug. According to the patient's preference, visits 6 and 7 may be combined.
Visit 4 (Week 3)
- Focused cardiopulmonary physical examination
- Vital signs
- Weight
- WHO FC assessment
- 6MWT
- Pregnancy test
- Hematology
- Urinalysis
- Clinical worsening assessment
- AE/SAE Review
- Concomitant medication review
Visit 5 (Week 5-6):
- PFT
- CPET
- QoL assessments
- AE/SAE Review
- Concomitant medication review
Visit 6 (Week 5-6):
- Hemoglobin
- Rest/exercise DLCO, VC, DM
- Rest/exercise CW-NIRS
- AE/SAE Review
- Concomitant medication review
Visit 7 (Week 5-6):
- Pregnancy test
- Rest/exercise Echocardiography
- AE/SAE Review
- Concomitant Medication review
Visit 8 (Week 6):
- Focused cardiopulmonary physical examination
- 6MWT
- Vital signs
- Weight
- WHO FC assessment
- Pregnancy test
- Hematology
- Urinalysis
- Clinical worsening assessment
- AE/SAE Review
- Concomitant medication review
Visit 9 (Week 9):
- Focused cardiopulmonary physical examination
- 6MWT
- 12-lead ECG
- Vital signs
- Weight
- WHO FC assessment
- Pregnancy test
- Hematology
- Serum chemistry
- NT-proBNP
- Clinical worsening assessment
- AE/SAE Review
- Concomitant medication review
Visit 10-14 (Week 12 - 24):
- Focused cardiopulmonary physical examination
- 6MWT
- Vital signs
- Weight
- WHO FC assessment
- Pregnancy test
- Hematology
- Urinalysis
- Clinical worsening assessment
- AE/SAE Review
- Concomitant medication review
End-of-Study Period (Visits 13-14) End-of-Study period visits will start 1 week after the last dose of the study medication and will be completed over 2 weeks. Visits 15-17 will be performed in Edmonton (site 1). Visit 16 and 17 can be performed on the same day according to patient preference.
Visit 15:
- Weight
- Hemoglobin
- PFT
- CPET
- QoL Assessment
- AE/SAE Review
- Concomitant medication review
Visit 16:
- Hemoglobin
- Rest/exercise DLCO, VC, DM
- Rest/exercise CW-NIRS
- AE/SAE Review
- Concomitant medication review
Visit 17:
- Rest/exercise echocardiography
- AE/SAE Review
- Concomitant medication review
Follow-up period (Visit 18) A follow-up visit will occur 3 weeks after the last dose of the study medication. For Edmonton participants (site 1), Visit 18 may happen on the same day after Visit 17 is completed.
Visit 18:
- 6MWT
- 12-lead ECG
- Vital signs
- WHO FC assessment
- Pregnancy test
- Hematology
- Urinalysis
- NT-proBNP sample collection
- Clinical worsening assessment
- AE/SAE Review
- Concomitant medication review
Following the last dose of study drug administration, participants have the option to continue with open label sotatercept supplied directly from the manufacturer until either the participant discontinues sotatercept or reimbursement through public or private insurance is in place. The treating physician will be responsible for ongoing monitoring and administration of sotatercept beyond the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sotatercept Group | Experimental | Drug: SotaterceptSotatercept 0.7mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (29 listed)
- 1. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
- Musculoskeletal limitation that precludes participation in cycle ergometry
- Resting oxygen saturation < 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen).
- Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease.
- Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test.
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 |
|---|---|---|
| SotaterceptAlso: Winrevair0.7mg/kg | Drug | Sotatercept Group |
Primary outcome
Lung diffusing capacity
Time frame: 6 weeks post starting treatment
Lung diffusing capacity (DLCO) will be measured using six-second, advanced DLCO techniques
Lung diffusing capacity
Time frame: 23 weeks post starting treatment
Lung diffusing capacity (DLCO) will be measured using six-second, advanced DLCO techniques
Diffusing membrane capacity (Dm)
Time frame: 6 weeks post starting treatment
Diffusing membrane capacity will be measured using six-second, advanced DLCO
Diffusing membrane capacity (Dm)
Time frame: 23 weeks post starting treatment
Diffusing membrane capacity will be measured using six-second, advanced DLCO
Pulmonary capillary blood volume (Vc)
Time frame: 6 weeks post starting treatment
Pulmonary capillary blood volume (Vc) will be measured using six-second, advanced DLCO techniques
Pulmonary capillary blood volume (Vc)
Time frame: 23 weeks post starting treatment
Pulmonary capillary blood volume (Vc) will be measured using six-second, advanced DLCO techniques
6 secondary outcomes
Cardiac structure and function
Time frame: 6 weeks post starting treatment
Cardiac structure and function
Time frame: 23 weeks post starting treatment
Cardiac function
Time frame: 6 weeks post starting treatment
Cardiac function
Time frame: 23 weeks post starting treatment
Peripheral muscle microcirculation
Time frame: 6 weeks post starting treatment
Peripheral muscle microcirculation
Time frame: 23 weeks post starting treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- 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.
Jason Weatherald, MD principal investigator
University of Alberta
Michael Stickland, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sotatercept in people with Pulmonary Artery Hypertension, run by University of Alberta at 1 site in Canada.
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 0 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Desi Fuhr, MSc (7804921121, fuhr@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung diffusing capacity (time frame: 6 weeks post starting treatment). The study lists 6 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 5 Nov 2026.