Status:
NOT_YET_RECRUITING
Efficacy and Safety of Treprostinil in Intermediate-Risk Pulmonary Arterial Hypertension
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Pulmonary Arterial Hypertension (PAH)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Pulmonary Arterial Hypertension (PAH) is a serious condition that puts strain on the right side of the heart. While oral medications can help, many patients with intermediate-risk PAH may not see enou...
Detailed Description
Background and Rationale: Pulmonary Arterial Hypertension (PAH) is a progressive vasculopathy leading to increased pulmonary vascular resistance, right ventricular (RV) failure, and mortality. While ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07177703
Start Date
October 31 2025
End Date
December 31 2027
Last Update
September 17 2025
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