Study Roles of Heavy Metals and Essential Metal Dyshomeostasis in Pulmonary Arterial Hypertension Patients
Part of paid clinical trials in Louisville, Kentucky.
- Sponsor
- Jiapeng Huang
- Study ID
- NCT04756076
- Status
- Recruiting
Conditions
- Metal Poison
- Pulmonary Hypertension
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Metal level measurements — DIAGNOSTIC_TESTMeasure multiple metal levels
Study Details
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.
Key Dates
- Start date
- Dec 2, 2020
- Status verified
- May 2025
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 110 participants (estimated)
Arms
- Arm: Controlage and gender matched controls
- Arm: Pulmonary Hypertension GroupPulmonary Hypertension Patients with Various Degree of Severity
Primary Outcome Measure
Metal levels in control and pulmonary hypertension groups [ Time Frame: up to 12 months ]
Central Contacts
- Jiapeng Huang, MD, PhD5028528157
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Louisville Health | Louisville | Kentucky | 40202 | Jiapeng Huang, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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