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

NCT04756076 | Recruiting

• 1 other identifier: 20.0947
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pulmonary Hypertension; Metal Poison

Outcome Measures

Primary Outcomes (1)

• Metal levels in control and pulmonary hypertension groups

  Metal levels in control and pulmonary hypertension groups

  up to 12 months

Secondary Outcomes (3)

• Right heart catheterization data

  up to 12 months

• Pulmonary hypertension risk scores (Registry to Evaluate Early and Long-Term PAH Disease Management)

  up to 12 months

• Mortality

  up to 12 months

Study Arms (2)

Control

age and gender matched controls

Diagnostic Test: Metal level measurements

Pulmonary Hypertension Group

Pulmonary Hypertension Patients with Various Degree of Severity

Diagnostic Test: Metal level measurements

Interventions

Metal level measurements DIAGNOSTIC_TEST

Measure multiple metal levels

Control; Pulmonary Hypertension Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary hypertension

You may qualify if:

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

You may not qualify if:

• Younger than 18 years
• Refusal to participate

Sponsors & Collaborators

• Jiapeng Huang: lead

Study Sites (1)

University of Louisville Health

Louisville, Kentucky, 40202, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Conditions

Hypertension, Pulmonary; Heavy Metal Poisoning

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders

Central Study Contacts

Jiapeng Huang, MD, PhD

CONTACT

5028528157; jiapeng.huang@louisville.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 16, 2021
• Study Start: December 2, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)