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The purpose of this study seeks to describe the real world initial experience with sotatercept in the treatment of pulmonary hypertension.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, Year 10 |
| Number of patient hospitalizations | Number of patient hospitalizations will be determined by the number of patients admitted into the hospital. | 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 | 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 | Baseline, Year 10 |
| Number of patients with bleeding complications |
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Inclusion Criteria:
Exclusion Criteria:
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Patients for whom sotatercept is being or has been prescribed will be identified through the Mayo Pulmonary Hypertension Clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hayden Halbach, M.B.A. | Contact | 507-255-2648 | Halbach.Hayden@mayo.edu | |
| Louise Durst, R.N. | Contact | 507-284-1838 |
| Name | Affiliation | Role |
|---|---|---|
| Robert Frantz, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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Bleeding complications include nosebleeds not requiring ER visit or transfusion, epistaxis or GI hemorrhage requiring ED visit/hospitalization.
| Baseline, Year 10 |
| Number of patients to develop Skin telangiectasias | Development of skin telangiectasias includes new development, worsening, or distribution | Baseline, Year 10 |
| Change in 6 min walk distance | 6 minute walk distance will be measured in meters (m). | 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 | 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. | 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. | Baseline, Year 10 |
| Change in Right Ventricle (RV) function | Change in RV function will be determined by echocardiogram and measured as a percentage. | Baseline, Year 10 |
| Change in capacitance | Capacitance is the ability for blood vessels to store and release blood. capacitance will be determined by echocardiogram. | Baseline, Year 10 |
| Change in tricuspid regurgitation | Tricuspid regurgitation is the regurgitation of blood into the right atrium during contraction of the heart. | 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 | 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 | 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. | 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. | Baseline, Year 10 |
| D002318 |
| Cardiovascular Diseases |