Treprostinil and Riociguat for Advanced Pulmonary Hypertension
Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH
Recruiting
Phase 3Interventional Study
Pulmonary Arterial Hypertension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
University of Arizona · Other
Who this trial is looking for
This trial is looking for people with advanced pulmonary arterial hypertension (PAH) to see if a combination of two drugs is more effective than one alone. Participants will receive treatment as directed by their pulmonary hypertension specialist.
Are You a Good Fit for This Trial?
Rules you outSevere restrictive lung diseaseObstructive lung diseaseHeart failure with preserved ejection fractionPulmonary veno-occlusive diseaseLife-threatening disease with life expectancy under 12 monthsModerate to severe hepatic impairment
You may be able to join if
I have been diagnosed with pulmonary arterial hypertension (PAH).
I have a resting mean pulmonary arterial pressure of 25 mmHg or higher.
My wedge pressure is 15 mmHg or lower during right heart catheterization.
My doctor has determined that I need parenteral Treprostinil.
You may not be able to join if
I have a mean arterial pressure below 60.
I will likely need device assistance or a lung transplant within 3 months.
I have a left ventricular ejection fraction below 50%.
I have severe lung disease.
I have a history of pulmonary embolism in the last three months.
I cannot undergo right heart catheterization.
I have received pulmonary vasoactive medication in the past 12 weeks.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to determine if there is a greater effect to patients with advanced pulmonary arterial hypertension (PAH) by using a combination of two drugs, Treprostinil and Riociquat versus Treprostinil alone
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* Patients with a mean arterial pressure \<60, and/or req…
Inclusion Criteria:
* 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 Criteria:
* 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).
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.