Pulmonary Hypertension
Conditions
Brief summary
The purpose of this study seeks to describe the real world initial experience with sotatercept in the treatment of pulmonary hypertension.
Interventions
None listed
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults age 18 or greater who are being treated with sotatercept in the Mayo Pulmonary hypertension clinic.
Exclusion criteria
* Adults lacking capacity to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EmPHasis10 Questionnaire | 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 | 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 | Baseline, Year 10 | A change in dose of prostanoid medications will be determined by a change from baseline dosage. |
| Number of patient hospitalizations | 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 | 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 | 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 | 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 | Baseline, Year 10 | Development of skin telangiectasias includes new development, worsening, or distribution |
| Change in 6 min walk distance | Baseline, Year 10 | 6 minute walk distance will be measured in meters (m). |
| Number of patients to have a change in hemodynamics | 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) | 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 | 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 | Baseline, Year 10 | Change in RV function will be determined by echocardiogram and measured as a percentage. |
| Change in capacitance | 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 | Baseline, 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 class | 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 | Baseline, Year 10 | A transplant is defined as receiving an organ or tissue from a donor. |
Countries
United States
Contacts
CONTACTHayden Halbach, M.B.A.
CONTACTLouise Durst, R.N.
PRINCIPAL_INVESTIGATORRobert Frantz, M.D.
Mayo Clinic
Outcome results
None listed