NCT04062565招募中3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in stroke volume/end systolic volume (SV/ESV)
研究概览
简要总结
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
详细描述
The purpose of this study is to evaluate the combined effect of parenteral treprostinil (TRE) and riociguat (RIO) versus parenteral TRE alone on right ventricular (RV)-pulmonary artery (PA) interaction (RVPA coupling) and global RV function in patients with advanced pulmonary arterial hypertension (PAH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Experimental
Experimental
Treprostinil and Riociguat
干预措施: Treprostinil Injectable Product (Drug)
Experimental
Experimental
Treprostinil and Riociguat
干预措施: Riociguat Pill (Drug)
结局指标
主要结局
Change in stroke volume/end systolic volume (SV/ESV)
时间窗: Baseline to 3 months
Change in stroke volume/end systolic volume (SV/ESV)
次要结局
- Change in Cardio pulmonary Exercise Testing (CPET)(3 months)
- Change in pulmonary and cardiac pressures(Baseline to 3 months)
- Change in pulmonary blood flow(Baseline to 3 months)
- Change in derived VO2 max(3 months)
- Change in derived Ve/VCO2(3 months)
- Change in adverse event profile(Baseline to 3 months)
- Change in end-systolic elastance/arterial elastance (Ees/Ea)(Baseline to 3 months)
- Change in Right Ventricle (RV) diastolic stiffness (Beta)(Baseline to 3 months)
- Change in 6 minute walk distance(Baseline to 3 months)
- Change in brain natriuretic peptide (BNP)(Baseline to 3 months)
- Change in magnetic resonance imaging (MRI) right ventricle volumes(Baseline to 3 months)
- Change in composite time to clinical worsening(Baseline to 3 months)
研究者
Franz Rischard, DO
Director, University of Arizona Pulmonary Hypertension Program
University of Arizona
研究点 (1)
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