Viewing Study NCT04756076



Ignite Creation Date: 2024-05-06 @ 3:47 PM
Last Modification Date: 2024-10-26 @ 1:57 PM
Study NCT ID: NCT04756076
Status: RECRUITING
Last Update Posted: 2024-02-14
First Post: 2021-02-07

Brief Title: Study Roles of Heavy Metals and Essential Metal Dyshomeostasis in Pulmonary Arterial Hypertension Patients
Sponsor: Jiapeng Huang
Organization: University of Louisville

Study Overview

Official Title: Study Roles of Heavy Metals and Essential Metal Dyshomeostasis in Pulmonary Arterial Hypertension Patients
Status: RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 bloodurine 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 PAHRV dysfunction over 12 months will be analyzed by CIEHS Biostatistics and Informatics Facility Core
Detailed Description: 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 metalsessential metal dyshomeostasis and right ventricular RV dysfunctionpulmonary hypertension PAH is less investigated Investigators hypothesize that increased toxic heavy metals andor essential metal dyshomeostasis impact hypoxia response endothelial dysfunction perivascular inflammation and vascular remodeling of the pulmonary vasculature and are important pathogenic initiatorsstimulators during the progression of PAH and associated RV remodelingdysfunction

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 bloodurine 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 PAHRV 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 metalessential 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None