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

NCT07177703 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-09-17

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07177703 on ClinicalTrials.gov