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NOT YET RECRUITING

NCT07177703

PHASE2

Efficacy and Safety of Treprostinil in Intermediate-Risk Pulmonary Arterial Hypertension

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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 enough improvement, and their heart function can continue to decline. This study aims to find out if adding an injectable medication, Treprostinil, to a patient's current oral PAH therapy can improve heart function and overall health. This is a single-arm study, which means all participants will receive the study treatment. The main goal is to measure the change in the amount of blood the right side of the heart pumps with each beat (Right Ventricular Stroke Volume, or RVSV) after 3 months of treatment. This will be measured using a specialized heart scan called Cardiac Magnetic Resonance Imaging (CMR). Researchers will also assess changes in exercise ability (with a 6-minute walk test), blood markers, and patient symptoms. Participants will be in the main part of the study for 3 months, with follow-up for a total of 24 months to monitor the long-term effects and safety of the treatment.

Official title: A Prospective Single-arm Exploratory Study on the Efficacy and Safety of Treprostinil Injection in the Treatment of Patients With Intermediate-risk Pulmonary Arterial Hypertension

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-10-31

Completion Date

2027-12-31

Last Updated

2025-09-17

Healthy Volunteers

Conditions

Pulmonary Arterial Hypertension (PAH)

Interventions

DRUG

Treprostinil

Treprostinil is initiated at a dose of 1.25 ng/kg/min. The dose is then titrated upwards based on individual patient tolerability and clinical response. The planned titration schedule is an increase of 1.25 ng/kg/min weekly for the first four weeks of treatment, followed by weekly increases of 2.5 ng/kg/min thereafter, as tolerated.

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.