Recruiting

Sotatercept

Sponsor:

Mayo Clinic

Code:

NCT06751082

Conditions

Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06751082

Start date

Jan 20, 2025

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]
  • Number of pulmonary hypertension vasodilator medications taken by a subject [ Time Frame: Baseline, Year 10 ]
  • Number of patients to have a change in dose of prostanoid medications [ Time Frame: Baseline, Year 10 ]
  • Number of patient hospitalizations [ Time Frame: Baseline, Year 10 ]
  • Number of patients to cease therapy sessions [ Time Frame: Baseline, Year 10 ]
  • Number of patients to discontinue prostanoid therapy [ Time Frame: Baseline, Year 10 ]
  • Number of patients with bleeding complications [ Time Frame: Baseline, Year 10 ]
  • Number of patients to develop Skin telangiectasias [ Time Frame: Baseline, Year 10 ]
  • Change in 6 min walk distance [ Time Frame: Baseline, Year 10 ]
  • Number of patients to have a change in hemodynamics [ Time Frame: Baseline, Year 10 ]
  • Change in Right Ventricular Systolic Pressure (RVSP) [ Time Frame: Baseline, Year 10 ]
  • Right Ventricular Strain [ Time Frame: Baseline, Year 10 ]
  • Change in Right Ventricle (RV) function [ Time Frame: Baseline, Year 10 ]
  • Change in capacitance [ Time Frame: Baseline, Year 10 ]
  • Change in tricuspid regurgitation [ Time Frame: Baseline, Year 10 ]
  • Change in Stroke Volume (SV) [ Time Frame: Baseline, Year 10 ]
  • Change in Pulse Pressure (PP) [ Time Frame: Baseline, Year 10 ]
  • Change in functional class [ Time Frame: Baseline, Year 10 ]
  • Number of patients to survive without receiving a transplant [ Time Frame: Baseline, Year 10 ]

Central Contacts and Locations

Central contacts

Louise Durst, R.N.

507-284-1838

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Robert Frantz, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-06.