Non-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 30
- 主要终点
- Change from Baseline in the Number of the Non-Invasive Low-Risk Criteria to 12 Months
研究概览
简要总结
The purpose of the study is to evaluate the change from baseline to 12 months after study enrollment in the number of the following non-invasive risk criteria: World Health Organization Functional Class (WHO/FC), 6-minute walk distance (6MWD), Brain Natriuretic Peptide (BNP) or N-terminal pro-brain Natriuretic Peptide (NT-proBNP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants in the clinical classification of pulmonary hypertension Group 1 (PAH)
- •Participants with idiopathic, heritable and associated forms of PAH (connective tissue disease, congenital heart disease corrected at least 1-year ago, human immunodeficiency virus infection, drug use or toxin, and porto-pulmonary)
- •Confirmed diagnosis of PAH with hemodynamic study right heart catheterization (RHC) at enrolment or at latest follow-up (not later than twelve months from enrolment date)
- •Participants with a low or intermediate mortality risk profile, as per clinical judgement based on a multiparametric approach including clinical, functional exercise, right ventricular function and hemodynamic parameters
- •Participants currently in treatment with selexipag and/or macitentan (in monotherapy or in combination therapy)
排除标准
- •Participants in Group 1 that are responders to the vasoreactivity test
- •Participants with pulmonary veno-occlusive disease (PVOD), defined on the basis of the following chest findings at high-resolution computed tomography (HRCT): centrilobular ground-glass opacities, smooth thickening of interlobular septa, mediastinal lymph node enlargement
- •Participants already in treatment with subcutaneous/intravenous prostanoids. Iloprost interventional (IV) (treatment of digital ulcers in systemic sclerosis [SSc] participants according to european league against rheumatism [EULAR] guidelines) is allowed
- •Participants currently enrolled in an interventional study
研究组 & 干预措施
Participants with PAH
Participants with confirmed diagnosis of pulmonary arterial hypertension (PAH) will be enrolled in the study and the data will be collected and observed to describe the application of European ESC/ERS guidelines and related 6th WSPH proceedings on risk assessment and related treatment strategy, in clinical practice.
干预措施: PAH medication (Drug)
结局指标
主要结局
Change from Baseline in the Number of the Non-Invasive Low-Risk Criteria to 12 Months
时间窗: Baseline and 12 Months
Change from baseline in the number of the non-invasive low-risk criteria will be assessed according to the following parameters: world health organization (WHO)/functional class (FC)- I, II, 6-minute walk distance (6MWD) greater than (\>) 440 meters (m), and brain natriuretic peptide (BNP) less than (\<) 50 nanogram per liter (ng/l) or N-terminal-pro-hormone brain natriuretic Peptide (NT-proBNP) \<300 ng/l.
次要结局
- Change in Progression in the Number of Participants with Low/High Intermediate Risk(Baseline up to 24 Months)
- Change from Baseline in Participants with Narrative plots(Baseline and 12 Months)
- Change from Baseline in Caregivers with Narrative Plots(Baseline and 12 Months)
- Number of Participants with Improved, Stable or Worsened Risk profile from Baseline to 12 and 24 Months(Baseline up to 12 and 24 Months)
- Overall Survival (OS)(Up to 24 Months)
- Change from Baseline in 6MWD(Baseline up to 24 Months)
- Change from Baseline in BNP or NT-proBNP(Baseline up to 24 Months)
- Change from Baseline in Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) 2.0 Risk Score up to 12 and 24 Months(Baseline up to 12 and 24 Months)
- Change from Baseline in Echocardiographic Parameters(Baseline up to 24 Months)
- Change from Baseline in Hemodynamic Parameters(Baseline up to 24 Months)
- Hospitalization Rate due to Worsening of PAH(Up to 24 Months)
- Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured with Emphasis-10 Questionnaire(Baseline up to 24 Months)
- Adherence to European Society of Cardiology and European Respiratory Society (ESC/ERS) guidelines and 6th World Symposium on Pulmonary Hypertension (WSPH)(Up to 24 Months)
- Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)(Up to 24 Months)