Pulmonary HypertensionNCT06751082
Real World Observational Study of Sotatercept for Pulmonary Hypertension
An observational study of Pulmonary Hypertension, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study seeks to describe the real world initial experience with sotatercept in the treatment of pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2025to Mar 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
Study population: Patients for whom sotatercept is being or has been prescribed will be identified through the Mayo Pulmonary Hypertension Clinic.
Who may be able to join
- Adults age 18 or greater who are being treated with sotatercept in the Mayo Pulmonary hypertension clinic.
Who cannot join
- Adults lacking capacity to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Louise Durst, R.N. contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Robert Frantz, M.D.
About this study
Official title: Sotatercept Pulmonary Hypertension Observational Registry
The purpose of this study seeks to describe the real world initial experience with sotatercept in the treatment of pulmonary hypertension.
- Conditions
- Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
EmPHasis10 Questionnaire
The EmPHasis10 Questionnaire consists of 10 questions to assess quality of life. The scores can range from 0-50, a higher score indicates a worse quality of life.
Measured: Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
Number of pulmonary hypertension vasodilator medications taken by a subject
Pulmonary hypertension vasodilator medications are used to decrease pressure in the pulmonary arteries.
Measured: Baseline, Year 10
Number of patients to have a change in dose of prostanoid medications
A change in dose of prostanoid medications will be determined by a change from baseline dosage.
Measured: Baseline, Year 10
Number of patient hospitalizations
Number of patient hospitalizations will be determined by the number of patients admitted into the hospital.
Measured: Baseline, Year 10
Number of patients to cease therapy sessions
Cease of therapy session will be determined by a patient's termination of all therapy sessions
Measured: Baseline, Year 10
Number of patients to discontinue prostanoid therapy
Number of patients to discontinue prostanoid therapy will be determined by a patients termination of all prostanoid therapy
Measured: Baseline, Year 10
Number of patients with bleeding complications
Bleeding complications include nosebleeds not requiring ER visit or transfusion, epistaxis or GI hemorrhage requiring ED visit/hospitalization.
Measured: Baseline, Year 10
Number of patients to develop Skin telangiectasias
Development of skin telangiectasias includes new development, worsening, or distribution
Measured: Baseline, Year 10
Change in 6 min walk distance
6 minute walk distance will be measured in meters (m).
Measured: Baseline, Year 10
Number of patients to have a change in hemodynamics
Change in hemodynamics include the change in Blood Flow, Blood Pressure, Cardiac Output, Vascular Resistance, Perfusion
Measured: Baseline, Year 10
Change in Right Ventricular Systolic Pressure (RVSP)
Right Ventricular Systolic Pressure is the pressure in the right ventricle during contraction. RVSP will be measured in mmHg.
Measured: Baseline, Year 10
Right Ventricular Strain
Right Ventricular Strain refers to strain on the right ventricle during contraction. Right Ventricular Strain will be determined by echocardiogram and measured as a percentage.
Measured: Baseline, Year 10
Change in Right Ventricle (RV) function
Change in RV function will be determined by echocardiogram and measured as a percentage.
Measured: Baseline, Year 10
Change in capacitance
Capacitance is the ability for blood vessels to store and release blood. capacitance will be determined by echocardiogram.
Measured: Baseline, Year 10
Change in tricuspid regurgitation
Tricuspid regurgitation is the regurgitation of blood into the right atrium during contraction of the heart.
Measured: Baseline, Year 10
Change in Stroke Volume (SV)
Stroke Volume is calculated by End-Diastolic Volume (EDV)-End-Systolic Volume (ESV) and measured in mL
Measured: Baseline, Year 10
Change in Pulse Pressure (PP)
Pulse Pressure is calculated by PP=systolic blood pressure (SBP) - diastolic blood pressure (DBP) and measured in mmHg
Measured: Baseline, Year 10
Change in functional class
Functional class refers to the severity of patients heart condition. A change in class would refer to the increase or decrease in severity of the condition.
Measured: Baseline, Year 10
Number of patients to survive without receiving a transplant
A transplant is defined as receiving an organ or tissue from a donor.
Measured: Baseline, Year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start20 Jan 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert P. Frantz, Mayo Clinic
- Investigators
- Robert Frantz, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751082
- Sponsor's protocol ID
- 24-011370
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sotatercept Pulmonary Hypertension Observational Registry
- ClinicalTrials.gov ID
- NCT06751082
- Acronym / sponsor ID
- 24-011370
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Dec 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 seeks to describe the real world initial experience with sotatercept in the treatment of pulmonary hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for whom sotatercept is being or has been prescribed will be identified through the Mayo Pulmonary Hypertension Clinic.
Key inclusion criteria (1 listed)
- Adults age 18 or greater who are being treated with sotatercept in the Mayo Pulmonary hypertension clinic.
Key exclusion criteria (1 listed)
- Adults lacking capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EmPHasis10 Questionnaire
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
The EmPHasis10 Questionnaire consists of 10 questions to assess quality of life. The scores can range from 0-50, a higher score indicates a worse quality of life.
Number of pulmonary hypertension vasodilator medications taken by a subject
Time frame: Baseline, Year 10
Pulmonary hypertension vasodilator medications are used to decrease pressure in the pulmonary arteries.
Number of patients to have a change in dose of prostanoid medications
Time frame: Baseline, Year 10
A change in dose of prostanoid medications will be determined by a change from baseline dosage.
Number of patient hospitalizations
Time frame: Baseline, Year 10
Number of patient hospitalizations will be determined by the number of patients admitted into the hospital.
Number of patients to cease therapy sessions
Time frame: Baseline, Year 10
Cease of therapy session will be determined by a patient's termination of all therapy sessions
Number of patients to discontinue prostanoid therapy
Time frame: Baseline, Year 10
Number of patients to discontinue prostanoid therapy will be determined by a patients termination of all prostanoid therapy
Number of patients with bleeding complications
Time frame: Baseline, Year 10
Bleeding complications include nosebleeds not requiring ER visit or transfusion, epistaxis or GI hemorrhage requiring ED visit/hospitalization.
Number of patients to develop Skin telangiectasias
Time frame: Baseline, Year 10
Development of skin telangiectasias includes new development, worsening, or distribution
Change in 6 min walk distance
Time frame: Baseline, Year 10
6 minute walk distance will be measured in meters (m).
Number of patients to have a change in hemodynamics
Time frame: Baseline, Year 10
Change in hemodynamics include the change in Blood Flow, Blood Pressure, Cardiac Output, Vascular Resistance, Perfusion
Change in Right Ventricular Systolic Pressure (RVSP)
Time frame: Baseline, Year 10
Right Ventricular Systolic Pressure is the pressure in the right ventricle during contraction. RVSP will be measured in mmHg.
Right Ventricular Strain
Time frame: Baseline, Year 10
Right Ventricular Strain refers to strain on the right ventricle during contraction. Right Ventricular Strain will be determined by echocardiogram and measured as a percentage.
Change in Right Ventricle (RV) function
Time frame: Baseline, Year 10
Change in RV function will be determined by echocardiogram and measured as a percentage.
Change in capacitance
Time frame: Baseline, Year 10
Capacitance is the ability for blood vessels to store and release blood. capacitance will be determined by echocardiogram.
Change in tricuspid regurgitation
Time frame: Baseline, Year 10
Tricuspid regurgitation is the regurgitation of blood into the right atrium during contraction of the heart.
Change in Stroke Volume (SV)
Time frame: Baseline, Year 10
Stroke Volume is calculated by End-Diastolic Volume (EDV)-End-Systolic Volume (ESV) and measured in mL
Change in Pulse Pressure (PP)
Time frame: Baseline, Year 10
Pulse Pressure is calculated by PP=systolic blood pressure (SBP) - diastolic blood pressure (DBP) and measured in mmHg
Change in functional class
Time frame: Baseline, Year 10
Functional class refers to the severity of patients heart condition. A change in class would refer to the increase or decrease in severity of the condition.
Number of patients to survive without receiving a transplant
Time frame: Baseline, Year 10
A transplant is defined as receiving an organ or tissue from a donor.
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 6 Apr 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.
Louise Durst, R.N. contact
Robert Frantz, M.D. 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?
An observational study of Pulmonary 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 1 inclusion and 1 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 6 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.
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 Hayden Halbach, M.B.A. (507-255-2648, Halbach.Hayden@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EmPHasis10 Questionnaire (time frame: Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10). The study lists 19 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 6 Apr 2026.