SOFAPI
Key facts
- Where
- Brest, FranciaországSee the site
- Phase
- 3. fázis
Where in Franciaország
- Centre Hospitalier Régional et Universitaire de BrestBrest, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Regional Et Universitaire De Brest
- Trial code
- EU 2025-520731-17-02
- Record updated
- 2026. szeptember 15.
- Original description
Our first objective is to assess whether [68Ga]Ga-FAPI PET/CT imaging can non-invasively assess pulmonary artery remodeling in PAH patients.Read full original descriptionShow less
68Ga-FAPI PET/CT imaging to assess pulmonary artery and right ventricle remodeling SoFAPI study
Our first objective is to assess whether [68Ga]Ga-FAPI PET/CT imaging can non-invasively assess pulmonary artery remodeling in PAH patients.
Inclusion: 18 years old or more; Documented diagnostic right heart catheterization (RHC) within 12 months of screening documenting a minimum PVR of ≥ 4 Wood units and pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤ 15 mmHg, with the diagnosis of WHO PAH Group 1 in any of the following subtypes: o Idiopathic PAH o Heritable PAH o Drug/toxine-induced PAH o PAH associated with connective tissue disease o PAH associated with simple, congenital systemic-to- pulmonary shunts at least 1year following repair; Patients under bi or tri-background-therapy; Symptomatic PAH classified WHO FC II or III; Patients will be started on Sotatercept; Ability to adhere to study visit schedule and understand and comply with all the protocol requirement; Ability to understand and provide written informed consent.
Exclusion: Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis; A known allergy has been identified with sotatercept (ACE-011), its excipients, or luspatercept; Hemoglobin at screening above gender-specific ULN, per local laboratory test; Any of the following clinical laboratory values at the Screening Visit: - eGFR < 30 mL/min/1.73 m2 (as defined by MDRD equation) - Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels > 3 × ULN; Diagnosis of PH WHO Groups 2, 3, 4, or 5; Pregnant or breastfeeding women.