BridgeMD
New treatment option for Pulmonary Arterial Hypertension
Official title Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH
ClinicalTrials.gov ID: NCT04062565
What this study is testing
What is Treprostinil Injectable Product?
Treprostinil Injectable Product is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pulmonary arterial hypertension.
Also referred to as Remodulin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- 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...
- 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 \ 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.