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Pulmonary HypertensionNCT04756076

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

An observational study of Pulmonary Hypertension and Metal Poison, run by Jiapeng Huang at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pulmonary Hypertension, Metal Poison
What is being tested?
Metal level measurements
How many people
110 participants
Where
1 siteUnited States
Study dates
2 Dec 2020to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with pulmonary hypertension

Who may be able to join

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

Who cannot join

  • Younger than 18 years
  • Refusal to participate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jiapeng Huang, MD, PhD contact

5028528157

jiapeng.huang@louisville.edu

United States1 site, 1 recruiting
  • University of Louisville Health

    Louisville, Kentucky, 40202

    Jiapeng Huang, MD, PhD, 5028528157, jiapeng.huang@louisville.edu

    Jiapeng Huang, MD, PhD

    Recruiting

Other trials in United States

About this study

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.

Read the 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 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.

Being tested
Metal level measurements
Medical subject headings
Hypertension, Pulmonary, Heavy Metal Poisoning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metal level measurementsDiagnostic test

    Measure multiple metal levels

Study groups in NCT04756076
Study groupRoleWhat they receive
Controlage and gender matched controls
Receives: Diagnostic Test: Metal level measurements
Pulmonary Hypertension GroupPulmonary Hypertension Patients with Various Degree of Severity
Receives: Diagnostic Test: Metal level measurements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metal levels in control and pulmonary hypertension groups

    Metal levels in control and pulmonary hypertension groups

    Measured: up to 12 months

Secondary outcomes (3)
  1. Right heart catheterization data

    mean pulmonary artery pressure (mmHg)

    Measured: up to 12 months

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

    Pulmonary hypertension risk scores, 0-10, the higher score means a worse outcome.

    Measured: up to 12 months

  3. Mortality

    death

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2021
  2. Study start2 Dec 2020
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04756076
Sponsor's protocol ID
20.0947
Status last verified
May 2025
First submitted
7 Feb 2021
Last updated
30 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Hypertension and Metal Poison, run by Jiapeng Huang at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiapeng Huang, MD, PhD (5028528157, jiapeng.huang@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metal levels in control and pulmonary hypertension groups (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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