Real World Observational Study of Sotatercept for Pulmonary Hypertension

NCT06751082 | Enrolling By Invitation

• 1 other identifier: 24-011370
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study seeks to describe the real world initial experience with sotatercept in the treatment of pulmonary hypertension.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (19)

• 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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients for whom sotatercept is being or has been prescribed will be identified through the Mayo Pulmonary Hypertension Clinic.

You may qualify if:

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

You may not qualify if:

• Adults lacking capacity to consent

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert Frantz, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2035
• Last Updated: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)