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临床试验/NCT04756076
NCT04756076招募中不适用

Study Roles of Heavy Metals and Essential Metal Dyshomeostasis in Pulmonary Arterial Hypertension Patients

Jiapeng Huang1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
110
试验地点
1
主要终点
Metal levels in control and pulmonary hypertension groups

研究概览

简要总结

Investigators plan to recruit 50 PAH patients from UofL PAH Clinic, with various degrees of severity (25 intermediate risk patients and 20 high risk patients) and 10 age and gender matched controls. PAH patients are evaluated at least every 6 months by the PAH Clinic and blood/urine samples will be obtained at each office visit. Blood, plasma and urine samples will be used to measure 31 metal levels including heavy metals (cadmium, arsenic, cobalt, lead etc.) and essential metals (calcium, copper, iron, zinc, potassium etc.) by the with ICP-MS via the service of ITEMFC. Interactions among the 31 metals in PAH patients, metal concentration differences between intermediate risk PAH, high risk PAH and control groups, the correlation between metal concentrations and the etiology, severity, duration, treatment, and progression of PAH/RV dysfunction over 12 months will be analyzed by CIEHS Biostatistics and Informatics Facility Core.

详细描述

Exposures to heavy metals such arsenic, lead, cadmium have been linked to increased incidence of cardiovascular disease (CVD). However, current studies suffer from multiple drawbacks, most studies were cross sectional in design, focused on individual metals without consideration of the joint effects of multiple metals, and did not examine the possible effects of essential metals in CVD. Especially, the relationship between heavy metals/essential metal dyshomeostasis and right ventricular (RV) dysfunction/pulmonary hypertension (PAH), is less investigated. Investigators hypothesize that increased toxic heavy metals and/or essential metal dyshomeostasis impact hypoxia response, endothelial dysfunction, perivascular inflammation and vascular remodeling of the pulmonary vasculature, and are important pathogenic initiators/stimulators during the progression of PAH and associated RV remodeling/dysfunction.

Investigators plan to recruit 50 PAH patients from UofL PAH Clinic, with various degrees of severity (25 intermediate risk patients and 20 high risk patients) and 10 age and gender matched controls. PAH patients are evaluated at least every 6 months by the PAH Clinic and blood/urine samples will be obtained at each office visit. Blood, plasma and urine samples will be used to measure 31 metal levels including heavy metals (cadmium, arsenic, cobalt, lead etc.) and essential metals (calcium, copper, iron, zinc, potassium etc.) by the with ICP-MS via the service of ITEMFC. Interactions among the 31 metals in PAH patients, metal concentration differences between intermediate risk PAH, high risk PAH and control groups, the correlation between metal concentrations and the etiology, severity, duration, treatment, and progression of PAH/RV dysfunction over 12 months will be analyzed by CIEHS Biostatistics and Informatics Facility Core.

Heavy metals have the potential of generating reactive oxygen species (ROS) and oxidative stress whenever the release of ROS exceeds endogenous antioxidant capacity. Therefore, investigators hypothesize that heavy metal/essential metal dyshomeostasis could induce oxidative stress responses, activate two key pulmonary vasculature regulators (endothelin 1 and hypoxia inducible factor (HIF) pathways), and in turn contributes to the PAH pathogenesis and RV dysfunction. Oxidative stress, endothelin 1 and HIF pathway markers in the blood will be measured with ELISA kits in both PAH and control groups. Investigators will perform comprehensive correlation analysis between metal levels, oxidative stress markers, endothelin 1 and HIF pathway markers, and quantitative clinical biomarkers such as hemodynamic, laboratory and functional data in PAH patients. Furthermore, investigators will perform correlation analysis between blood levels of oxidative stress, endothelin 1 and HIF pathway markers and the patients' dietary intake of antioxidant vegetables.

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

入选标准

  • All patients with the diagnosis of pulmonary hypertension
  • Agree to the study protocol
  • Healthy volunteers
  • Age, gender matched controls

排除标准

  • Younger than 18 years
  • Refusal to participate

结局指标

主要结局

Metal levels in control and pulmonary hypertension groups

时间窗: up to 12 months

Metal levels in control and pulmonary hypertension groups

次要结局

  • Mortality(up to 12 months)
  • Pulmonary hypertension risk scores (Registry to Evaluate Early and Long-Term PAH Disease Management)(up to 12 months)
  • Right heart catheterization data(up to 12 months)

研究者

发起方
Jiapeng Huang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jiapeng Huang

Principal Investigator

University of Louisville

研究点 (1)

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