Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH
A Prospective Trial to Evaluate Up-front Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Patients With Advanced Pulmonary Arterial Hypertension (IIR-3810)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether treprostinil plus riociguat works better than treprostinil alone. It is for people with advanced pulmonary arterial hypertension (PAH), a type of high blood pressure in the lungs.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have WHO Group 1 PAH, a type of high blood pressure in the lung arteries.
- Have lung artery pressure of at least 25 mmHg at rest and wedge pressure of 15 mmHg or less. These are measured with a thin tube placed in the heart.
- Need treprostinil given by infusion, as decided by your lung blood pressure specialist.
Who can't join
- Have very low blood pressure, need medicine to support blood pressure, or are expected to need a heart-lung support device or lung transplant within 3 months.
- Have certain heart pumping or valve problems, severe lung disease, other types of lung high blood pressure, or certain lung vein or small blood vessel diseases.
- Have a lung blood clot within the past 3 months, ongoing lung clots, or a reason that makes the heart tube test unsafe. Recent coughing up blood or past severe bleeding needing treatment also excludes you.
- Have moderate or severe liver disease, very poor kidney function, high liver blood test results, or very low hemoglobin, the protein that carries oxygen in blood.
- Are pregnant or breastfeeding. Women must avoid sex or use two highly effective birth control methods as required by the study.
- Weigh less than 40 kg or more than 150 kg, have another life-threatening illness with expected survival under 12 months, or cannot follow study requirements.
- Have used medicines that act on lung blood vessels within 12 weeks, nitrates within 4 weeks, or another study drug within 1 month. Planned use of another study drug also excludes you.
- Take certain interacting medicines, including theophylline or medicines that may greatly lower blood pressure with riociguat, or have allergies to these types of study drugs or their ingredients.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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).
Study sites (1)
AZ
- University of Arizona · Tucson, AZ 85724Valerie Bloss, MS · Study contact · 520-626-8305 · vbloss@email.arizona.eduFranz Rischard, DO · Principal investigatorMore trials in Tucson