What is the Role of the Exposome in Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 10
- 主要终点
- To compare the exposome assessed based on the concentration of 190 environmental toxins, drugs and medications of interest in the hair and urine of patients newly diagnosed with PAH or CTEPH
研究概览
简要总结
Pulmonary arterial hypertension (PAH) is a rare and incurable disease affecting people of all ages. It is characterized by obstructive remodeling of the small pulmonary arteries, responsible for an increase in pulmonary arterial pressure, leading to right heart failure and death in the absence of treatment. PAH can be associated with a variety of diseases, but around half of all PAH cases are idiopathic or hereditary, and may develop on predisposed terrain following a "second hit", as suggested by the identification of PAH cases associated with the use of anorectic drugs, methamphetamine and occupational exposure to organic solvents. No study has systematically analyzed the exposome of patients with PAH, combining environmental and occupational exposures as well as drugs and medications.
The exposome of patients with PAH without associated causes will be compared with that of patients with another form of pulmonary hypertension (PH), linked to thromboembolic risk factors: chronic thromboembolic PH (CTEPH), which will constitute the control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Consent signed by the participant
- •Age ≥ 18 years
- •Free subject, under no legal protection
- •Good understanding of the French language, allowing to answer the questionnaires
- •Patients with pre-capillary PH confirmed by cardiac catheterization (PAPm > 20mmHg, PCP ≤ 15 mmHg, RVP > 2UW) having had the right diagnostic cardiac catheterization within one year (≤1 year) :
- •Cases: Patients with PAH without associated pathology: idiopathic or heritable, or with features of venous/capillary involvement, according to the clinical classification of PH
- •Controls: Patients with chronic thromboembolic PH (CTEPH, class 4), according to the clinical classification of PH.
排除标准
- •Patients classified as HTP groups 2, 3 or 5
- •Patients with a diagnosis of PAH associated with a connective tissue disease, HIV, portal hypertension, congenital heart disease, bilharzia, or a drug or toxic cause considered certain according to the international classification (Aminorex, Benfluorex, Carfilzomib, Dasatinib, Dexfenfluramine, Fenfluramine, Methamphetamines, Mitomycin C, adulterated rapeseed oil)
- •Patients with signs of right heart failure requiring amines and/or intensive care hospitalization at time of visit (may be included at a later visit)
- •Patients refusing hair sampling or having no hair > 2 cm to allow sampling
- •Patients benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection, and patients in emergency situations
研究组 & 干预措施
PAH group (cases)
Patients with PAH without associated pathology: idiopathic or heritable, or with features of venous/capillary involvement, according to the clinical classification of PH
干预措施: Questionnaires (Other)
PAH group (cases)
Patients with PAH without associated pathology: idiopathic or heritable, or with features of venous/capillary involvement, according to the clinical classification of PH
干预措施: Samples (Other)
CTEPH group (controls)
Patients with chronic thromboembolic PH (CTEPH, class 4), according to the clinical classification of PH
干预措施: Questionnaires (Other)
CTEPH group (controls)
Patients with chronic thromboembolic PH (CTEPH, class 4), according to the clinical classification of PH
干预措施: Samples (Other)
结局指标
主要结局
To compare the exposome assessed based on the concentration of 190 environmental toxins, drugs and medications of interest in the hair and urine of patients newly diagnosed with PAH or CTEPH
时间窗: From enrollement to the end of study at day 1
To compare the concentration of 180 environmental toxins of interest in the hair and urine of patients with newly diagnosed PAH and CTEPH, diagnosed in one of the reference or competence centers of the French PAH network.
时间窗: From enrollement to the end of study at day 1
次要结局
- To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of outdoor and indoor environmental exposures(From enrollement to the end of study at day 1)
- To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of occupational exposures(From enrollement to the end of study at day 1)
- To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of medications exposures(From enrollement to the end of study at day 1)
- To compare the exposome of patients newly diagnosed with PAH or CTEPH in terms of drug exposures(From enrollement to the end of study at day 1)
- Compare broad screening of hair and urine for environmental toxicants and drugs in PAH and CTEPH patients(From enrollement to the end of study at day 1)
- Compare each of the 4 exposure domains (toxic agents (drugs and medications), occupational exposures, environmental exposures and socioeconomic factors) individually between PAH and CTEPH patients.(From enrollement to the end of study at day 1)
- Compare the exposome of PAH patients and CTEPH patients, divided into 4 domains including toxic agents using a combination of direct measurements on hair and urine and indirect measurements via questionnaires.(From enrollement to the end of study at day 1)