Recruiting

Observational Study

Sponsor:

Jiapeng Huang

Code:

NCT04756076

Conditions

Pulmonary Hypertension

Metal Poison

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Metal level measurements

Study Details

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

Study ID

NCT04756076

Start date

Dec 2, 2020

Status verified date

May, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Younger than 18 years
  • Refusal to participate

Study Design

Enrollment

110 participants

Anticipated

Interventions and Outcome Measures

Arms

Control

age and gender matched controls

Pulmonary Hypertension Group

Pulmonary Hypertension Patients with Various Degree of Severity

Interventions

Metal level measurements

Measure multiple metal levels

Primary outcome measure

  • Metal levels in control and pulmonary hypertension groups [ Time Frame: up to 12 months ]

Central Contacts and Locations

Central contacts

Locations

University of Louisville Health

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator:

Jiapeng Huang, MD, PhD

More Information

Sponsor

Jiapeng Huang

Last update posted

May 30, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jiapeng Huang on 2025-05-30.