Real World Observational Study of Sotatercept for Pulmonary Hypertension

• Conditions: Pulmonary Hypertension

• Registration Number: NCT06751082
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-27
• Study Start: 2025-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2035-01
• Study Completion: 2035-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States