Pulmonary Arterial HypertensionPhase 4NCT06409026
Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension
A Phase 4 study testing Sotatercept in people with Pulmonary Arterial Hypertension, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to see if the drug sotatercept given for 36 weeks improves the functioning of the heart and improves quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Sotatercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2024to 14 Jan 2026
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- NYHA Class II-IV.
- LVEF ≥ 40 % within the preceding year.
- No recent initiation of pulmonary vasodilator in the last 60 days.
- Pulmonary arterial hypertension by right heart catheterization (Mean PA pressure ≥ 20 mmHg with PVR>2 Wood units) with no evidence of heart failure with preserved ejection fraction (exercise PCWP <25 mm Hg).
- Symptomatic PAH patients with plan to undergo exercise RHC for reassessment of exertional symptoms.
Who cannot join
- Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
- Planned coronary, carotid, or peripheral artery revascularization.
- Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease).
- Wheelchair bound or orthopedic inability to exercise.
- Chronic hypoxemia with inability to exercise without oxygen supplementation.
- Skeletal muscle myopathy.
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- History of rhabdomyolysis.
- Participation in any clinical trial of an approved or non-approved device for the treatment of pulmonary hypertension within 30 days before screening.
- Receipt of any investigational medicinal product within 30 days before screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
- Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Effect of Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension
The purpose of this study is to see if the drug sotatercept given for 36 weeks improves the functioning of the heart and improves quality of life.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Sotatercept
- 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.
SotaterceptDrug
As per FDA indications, sotatercept will be administered as 0.3 mg/kg injection for the first dose followed by 0.7 mg/kg injections for subsequent doses.
| Study group | Role | What they receive |
|---|---|---|
| Sotatercept Therapy | Experimental | All participants will receive 36 weeks of sotatercept therapy. Sotatercept is administered as a subcutaneous injection once every 3 weeks. Receives: Drug: Sotatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise
Peak exercise pulmonary arterial mean pressure/ Cardiac output (mm Hg/L/min)
Measured: Baseline, Week 24
Secondary outcomes (18)
Oxygen Consumption (VO2)
VO2 will be measured in mL/kg/min. It will be directly measured using expired gas analysis.
Measured: Baseline, 24 weeks
Single leg blood flow at peak exercise
Single leg blood flow will be obtained from venous access. Single leg blood flow will be measured in ml/min
Measured: Baseline, 24 weeks
Pulmonary vascular resistance at rest
Pulmonary vascular resistance will be measured in Wood units (mmHg/L/min)
Measured: Baseline, 24 weeks
Pulmonary vascular resistance at peak exercise
Pulmonary vascular resistance will be measured in Wood units (mmHg/L/min)
Measured: Baseline, 24 weeks
Pulmonary arterial (PA) compliance at rest
PA compliance measures pulmonary arterial distensibility and will be recorded at Baseline and 24 Weeks. PA compliance will be measured in ml/mm Hg.
Measured: Baseline, 24 weeks
Pulmonary arterial (PA) compliance at peak exercise
PA compliance measures pulmonary arterial distensibility and will be recorded at Baseline and 24 Weeks. PA compliance will be measured in ml/mm Hg.
Measured: Baseline, 24 weeks
Pulmonary arterial elastance at rest
PA elastance measures pulmonary artery stiffness and will be recorded at baseline and 24 weeks as PA systolic pressure/stroke volume (units mm Hg/ml)
Measured: Baseline, 24 weeks
Pulmonary arterial elastance at peak exercise
PA elastance measures pulmonary artery stiffness and will be recorded at baseline and 24 weeks as PA systolic pressure/stroke volume (units mm Hg/ml)
Measured: Baseline, 24 weeks
Left ventricular (LV) transmural pressure at rest
LV transmural pressure will measured by catheterization at Baseline and 24 Weeks as the difference between pulmonary capillary wedge pressure and right atrial pressure
Measured: Baseline, 24 weeks
Left ventricular (LV) transmural pressure at peak exercise
LV transmural pressure will measured by catheterization at Baseline and 24 Weeks as the difference between pulmonary capillary wedge pressure and right atrial pressure
Measured: Baseline, 24 weeks
Right Ventricular Pulmonary Artery Coupling at rest
Calculated as the ratio of RV function by echocardiography indexed to PA systolic pressure (unit mmHg-1)
Measured: Baseline, 24 weeks
Right Ventricular Pulmonary Artery Coupling at peak exercise
Calculated as the ratio of RV function by echocardiography indexed to PA systolic pressure (unit mmHg-1)
Measured: Baseline, 24 weeks
Eccentricity index at rest
Eccentricity index will be calculated as the ratio of antero posterior and septolateral dimension of the left ventricle by echocardiogram
Measured: Baseline, 24 weeks
Eccentricity index at peak exercise
Eccentricity index will be calculated as the ratio of antero posterior and septolateral dimension of the left ventricle by echocardiogram
Measured: Baseline, 24 weeks
Right atrial pressure (RA) at rest
RA pressure (mm Hg) will be measured by catheterization conducted at Baseline and 24 weeks
Measured: Baseline, 24 weeks
Right atrial pressure (RA) at peak exercise
RA pressure (mm Hg) will be measured by catheterization conducted at Baseline and 24 weeks
Measured: Baseline, 24 weeks
Change in skeletal muscle O2 diffusive conductance (Dm) during peak exercise
Dm is measured in ml/mm Hg/min during peak exercise
Measured: Baseline, 24 weeks
Change in skeletal muscle O2 diffusive conductance (Dm) during single leg exercise
Dm is measured in ml/mm Hg/min during single leg exercise
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start5 Jul 2024
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yogesh Reddy, Mayo Clinic
- Investigators
- Yogesh Reddy, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409026
- Sponsor's protocol ID
- 24-002570
- Status last verified
- Apr 2026
- First submitted
- 7 May 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reddy YNV, Kazui S, Miranda WR, Harada T, Frantz RP, Burkhoff D, Borlaug BA. Sotatercept Improves Right Heart Mechanics Despite Reduced Myocardial Contractility in Pulmonary Arterial Hypertension: A Prospective Exercise Hemodynamic Study. Circulation. 2026 Sep 22. doi: 10.1161/CIRCULATIONAHA.126.081334. Online ahead of print.
PubMed 42770225Reddy YNV, Frantz RP, Miranda WR, Harada T, Kazui S, Borlaug BA. Sotatercept in Pulmonary Arterial Hypertension: Central, Hematologic, and Peripheral Mechanisms of Benefit. J Am Coll Cardiol. 2026 Jul 28;88(4):415-432. doi: 10.1016/j.jacc.2026.02.5103. Epub 2026 Mar 2.
PubMed 41885673
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06409026
- Acronym / sponsor ID
- 24-002570
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 10 May 2024 (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 purpose of this study is to see if the drug sotatercept given for 36 weeks improves the functioning of the heart and improves quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sotatercept Therapy | Experimental | Drug: SotaterceptAll participants will receive 36 weeks of sotatercept therapy. Sotatercept is administered as a subcutaneous injection once every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- NYHA Class II-IV.
- LVEF ≥ 40 % within the preceding year.
- No recent initiation of pulmonary vasodilator in the last 60 days.
- Pulmonary arterial hypertension by right heart catheterization (Mean PA pressure ≥ 20 mmHg with PVR>2 Wood units) with no evidence of heart failure with preserved ejection fraction (exercise PCWP <25 mm Hg).
Key exclusion criteria (12 listed)
- Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
- Planned coronary, carotid, or peripheral artery revascularization.
- Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease).
- Wheelchair bound or orthopedic inability to exercise.
- Chronic hypoxemia with inability to exercise without oxygen supplementation.
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 |
|---|---|---|
| SotaterceptAs per FDA indications, sotatercept will be administered as 0.3 mg/kg injection for the first dose followed by 0.7 mg/kg injections for subsequent doses. | Drug | Sotatercept Therapy |
Primary outcome
Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise
Time frame: Baseline, Week 24
Peak exercise pulmonary arterial mean pressure/ Cardiac output (mm Hg/L/min)
18 secondary outcomes
Oxygen Consumption (VO2)
Time frame: Baseline, 24 weeks
Single leg blood flow at peak exercise
Time frame: Baseline, 24 weeks
Pulmonary vascular resistance at rest
Time frame: Baseline, 24 weeks
Pulmonary vascular resistance at peak exercise
Time frame: Baseline, 24 weeks
Pulmonary arterial (PA) compliance at rest
Time frame: Baseline, 24 weeks
Pulmonary arterial (PA) compliance at peak exercise
Time frame: Baseline, 24 weeks
Pulmonary arterial elastance at rest
Time frame: Baseline, 24 weeks
Pulmonary arterial elastance at peak exercise
Time frame: Baseline, 24 weeks
Left ventricular (LV) transmural pressure at rest
Time frame: Baseline, 24 weeks
Left ventricular (LV) transmural pressure at peak exercise
Time frame: Baseline, 24 weeks
Right Ventricular Pulmonary Artery Coupling at rest
Time frame: Baseline, 24 weeks
Right Ventricular Pulmonary Artery Coupling at peak exercise
Time frame: Baseline, 24 weeks
Eccentricity index at rest
Time frame: Baseline, 24 weeks
Eccentricity index at peak exercise
Time frame: Baseline, 24 weeks
Right atrial pressure (RA) at rest
Time frame: Baseline, 24 weeks
Right atrial pressure (RA) at peak exercise
Time frame: Baseline, 24 weeks
Change in skeletal muscle O2 diffusive conductance (Dm) during peak exercise
Time frame: Baseline, 24 weeks
Change in skeletal muscle O2 diffusive conductance (Dm) during single leg exercise
Time frame: Baseline, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Derived from this study: PubMed 42770225Reddy YNV, Kazui S, Miranda WR, Harada T, Frantz RP, Burkhoff D, Borlaug BA. Sotatercept Improves Right Heart Mechanics Despite Reduced Myocardial Contractility in Pulmonary Arterial Hypertension: A Prospective Exercise Hemodynamic Study. Circulation. 2026 Sep 22. doi: 10.1161/CIRCULATIONAHA.126.081334. Online ahead of print.
- Derived from this study: PubMed 41885673Reddy YNV, Frantz RP, Miranda WR, Harada T, Kazui S, Borlaug BA. Sotatercept in Pulmonary Arterial Hypertension: Central, Hematologic, and Peripheral Mechanisms of Benefit. J Am Coll Cardiol. 2026 Jul 28;88(4):415-432. doi: 10.1016/j.jacc.2026.02.5103. Epub 2026 Mar 2.
- 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.
Yogesh Reddy, MBBS principal investigator
Mayo Clinic
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 Arterial Hypertension, run by Mayo Clinic 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 16 Apr 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 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06409026, which also lists 2 linked publications.
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 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.