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Observational Study of Sotatercept for Pulmonary Hypertension

This study is looking at how sotatercept works in real-world settings for people with pulmonary hypertension (high blood pressure in the lungs). It aims to understand the initial experiences of adults who are already taking sotatercept at the Mayo Pulmonary Hypertension Clinic. The study will track changes in your quality of life using a questionnaire (EmPHasis10), and look at the number and dosage of your pulmonary hypertension medications over a long period. We don't have information on the current recruitment status, but the study plans to include 120 participants.

Study design
This is an observational study, meaning researchers will watch and collect information about patients already taking sotatercept. It plans to include 120 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be followed for up to 10 years, with measurements taken at baseline and annually.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06751082

Real World Observational Study of Sotatercept for Pulmonary Hypertension

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~120 participants
Updated 2026-04-06 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
EmPHasis10 Questionnaire
Measured over Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
+18 more outcomes measured

Conditions

Pulmonary Hypertension

Explore related trials

Pulmonary Hypertension

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Robert Frantz, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Hayden Halbach, M.B.A.
[email protected]
507-255-2648
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults age 18 or greater who are being treated with sotatercept in the Mayo Pulmonary hypertension clinic.

Exclusion

Adults lacking capacity to consent

What this trial measures

  • EmPHasis10 QuestionnaireBaseline, 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 subjectBaseline, 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 medicationsBaseline, Year 10

    A change in dose of prostanoid medications will be determined by a change from baseline dosage.

  • Number of patient hospitalizationsBaseline, Year 10

    Number of patient hospitalizations will be determined by the number of patients admitted into the hospital.

  • Number of patients to cease therapy sessionsBaseline, Year 10

    Cease of therapy session will be determined by a patient's termination of all therapy sessions

  • Number of patients to discontinue prostanoid therapyBaseline, 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 complicationsBaseline, 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 telangiectasiasBaseline, Year 10

    Development of skin telangiectasias includes new development, worsening, or distribution

  • Change in 6 min walk distanceBaseline, Year 10

    6 minute walk distance will be measured in meters (m).

  • Number of patients to have a change in hemodynamicsBaseline, 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)Baseline, Year 10

    Right Ventricular Systolic Pressure is the pressure in the right ventricle during contraction. RVSP will be measured in mmHg.

  • Right Ventricular StrainBaseline, 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) functionBaseline, Year 10

    Change in RV function will be determined by echocardiogram and measured as a percentage.

  • Change in capacitanceBaseline, Year 10

    Capacitance is the ability for blood vessels to store and release blood. capacitance will be determined by echocardiogram.

  • Change in tricuspid regurgitationBaseline, Year 10

    Tricuspid regurgitation is the regurgitation of blood into the right atrium during contraction of the heart.

  • Change in Stroke Volume (SV)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)Baseline, Year 10

    Pulse Pressure is calculated by PP=systolic blood pressure (SBP) - diastolic blood pressure (DBP) and measured in mmHg

  • Change in functional classBaseline, 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 transplantBaseline, Year 10

    A transplant is defined as receiving an organ or tissue from a donor.