Real World Observational Study of Sotatercept for Pulmonary Hypertension

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.