Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT07177703
Eligibility Criteria:
Inclusion Criteria:
* Signed the informed consent form.
* Age between 18 and 75 years, inclusive.
* Diagnosed with Pulmonary Arterial Hypertension (PAH, WHO Group 1) of the following etiologies:Idiopathic;Heritable;Drug or toxin-induced (excluding amphetamine-induced PAH);Associated with repaired congenital systemic-to-pulmonary shunts (repair performed ≥1 year prior);Associated with connective tissue disease;Associated with HIV infection;
* Has undergone a right heart catheterization (RHC) within 6 months of the baseline visit.
* Baseline RHC demonstrates the following hemodynamics:Mean pulmonary arterial pressure (mPAP) \> 20 mmHg;Pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg;Pulmonary vascular resistance (PVR) \> 2 Wood units;
* WHO Functional Class II, III, or IV.
* Risk stratification according to 2022 ESC/ERS guidelines is either intermediate-risk at initial diagnosis or low- to intermediate-risk during follow-up.
* Patient is on a stable dose of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE-5i) or a soluble guanylate cyclase (sGC) stimulator for at least 30 days prior to baseline; OR, if treatment-naïve, is willing to initiate one of these therapies in addition to the study drug.
Exclusion Criteria:
* Age \< 18 years.
* Diagnosis of Pulmonary Hypertension belonging to WHO Groups 2, 3, 4, or 5.
* Patients undergoing dialysis.
* Severe hepatic impairment (Child-Pugh Class C).
* Use of any prostacyclin-pathway drugs (epoprostenol, treprostinil, iloprost, beraprost, or selexipag) within 30 days prior to the baseline visit.
* Presence of implanted metallic devices that would interfere with Cardiac - - - Magnetic Resonance (CMR) imaging, such as defibrillators, neurostimulators, cochlear implants, permanent infusion devices, implanted pumps, or certain plates/screws.
* In the investigator's judgment, the patient is unable to complete or comply with study requirements.
* Refusal to sign the informed consent form or refusal to participate in follow-up visits.
* Participation in any other clinical trial involving an investigational drug, device, or procedure within 30 days prior to the baseline visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07177703
Study Brief:
Protocol Section:
NCT07177703