Recruiting NCT06751082
Real World Observational Study of Sotatercept for Pulmonary Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sotatercept Pulmonary Hypertension Observational Registry
Overview
The purpose of this study seeks to describe the real world initial experience with sotatercept in the treatment of pulmonary hypertension.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT06751082 · 24-011370