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Study of Treprostinil and Riociguat for Advanced Pulmonary Arterial Hypertension

This study is looking at whether combining two medications, Treprostinil (an injectable drug) and Riociguat (a pill), works better than Treprostinil alone for people with advanced pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of the lungs. The study aims to see if the combination treatment improves how well your heart's right pumping chamber (ventricle) works with your lung arteries. To join, you must be 18 or older, have WHO Category I PAH, and need Treprostinil as determined by your specialist. The main goal is to measure changes in how much blood your heart pumps with each beat compared to its size over three months. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 20 participants. It compares the effects of Treprostinil and Riociguat together versus Treprostinil alone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured from baseline to 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04062565

Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH

Recruiting
PHASE3Ages 18+InterventionalTreatment
University of Arizona
~20 participants
Updated 2025-02-20 on ClinicalTrials.gov
What's tested:Treprostinil Injectable ProductRiociguat Pill

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in stroke volume/end systolic volume (SV/ESV)
Measured over Baseline to 3 months

Conditions

Pulmonary Arterial Hypertension

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Pulmonary Arterial Hypertension

NCT04062565

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Arizona

    Tucson, Arizonastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Franz Rischard, DO · PRINCIPAL_INVESTIGATOR · University of Arizona

Who to contact

Valerie Boss, MS
[email protected]
520-626-8305
Email the study team

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Eligibility criteria

Inclusion

WHO Category I PAH
Resting mPAP ≥ 25 mmHg with a wedge pressure of ≤ 15mmHg during right heart catheterization.
Need for parenteral TRE as determined by the PH specialist caring for the patient

Exclusion

Patients with a mean arterial pressure \<60, and/or requiring vasopressor support
Patients whom expected device (i.e. ECMO, RVAD) assistance or early pulmonary transplantation (within 3 months) seems inevitable
Patients with a left ventricular ejection fraction \<50% or clinical, echocardiographic, and/or catheterization data consistent with heart failure with preserved ejection fraction (HFpEF) and/or moderate-severe aortic or mitral valve abnormality
Patients with severe restrictive lung disease (FVC\<70% predicted) and/or obstructive lung disease (FEV1 \<70% predicted and FEV1/FVC \<70%).
Patients with a history of pulmonary embolism within the last three months or evidence of chronic pulmonary embolism.
Patients with a known contraindication to right heart catheterization.
Patients whom have received active or previous pulmonary vasoactive medication within the previous 12 weeks.
PAH associated with significant venous or capillary involvement (PCWP \> 15 mmHg), known pulmonary veno-occlusive disease, and pulmonary capillary hemangiomatosis.
Pulmonary Hypertension belonging to groups 2 to 5 of the WHO classification.
Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
Estimated creatinine clearance \< 30 mL/min
Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.5 times the upper limit of normal.
Hemoglobin \< 75% of the lower limit of the normal range.
Acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements.
Pregnant or breast-feeding.
Females must either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or
Use 2 medically acceptable, highly effective forms of contraception for the duration of study, and at least 30 after discontinuing study drug.
Known concomitant life-threatening disease with a life expectancy \< 12 months.
Body weight \< 40 kg and/or \>150 kg.
Any condition that prevents compliance with the protocol or adherence to therapy.
Concurrent therapy with strong CYP3A4 inhibitors/inducers (i.e. protease inhibitors, azole antibiotics, macrolides), theophylline, and any medication in the PI's opinion may substantially potentiate the hypotensive effect of RIO.
Treatment with nitrates of any kind within the 4 weeks prior to enrollment.
Known hypersensitivity to drugs of the same class as TRE and/or RIO, or any of their excipients.
Planned treatment, or treatment, with another investigational drug within 1 month prior to randomization.
Recent (\<6 months) hemoptysis and/or history of severe hemoptysis requiring intervention (bronchial artery embolization).

What this trial measures

  • Change in stroke volume/end systolic volume (SV/ESV)Baseline to 3 months

    Change in stroke volume/end systolic volume (SV/ESV)