Evaluating the effects of two drugs on heart function in patients with advanced pulmonary arterial hypertension
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)
This study is testing if a combination of two heart medications can improve heart function more than just one medication in people with advanced pulmonary arterial hypertension.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT04062565 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the combined effects of parenteral treprostinil and riociguat compared to treprostinil alone on right ventricular-pulmonary artery interaction and overall right ventricular function in patients suffering from advanced pulmonary arterial hypertension (PAH). The trial will involve administering these medications to participants and monitoring their heart function through various assessments. The goal is to determine if the combination therapy provides a greater benefit than the single drug treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with advanced pulmonary arterial hypertension who require parenteral treprostinil as determined by their pulmonary hypertension specialist.
Not a fit: Patients who may not benefit from this study include those with severe heart failure, significant lung disease, or those requiring immediate advanced cardiac support.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with advanced pulmonary arterial hypertension, potentially enhancing their heart function and overall quality of life.
How similar studies have performed: While the combination of these two drugs has not been extensively tested together, previous studies have shown promising results for each drug individually in treating pulmonary arterial hypertension.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Tucson, Arizona
- University of Arizona — Tucson, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Franz Rischard, DO — University of Arizona
- Study coordinator: Valerie Boss, MS
- Email: vbloss@email.arizona.edu
- Phone: 520-626-8305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.