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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2024 to Dec 31, 2028
    • Study completion date: Dec 31, 2024 to Dec 31, 2029
    • Site contact updated
    v5
  2. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024v4
  3. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04756076
Lead Sponsor Jiapeng Huang
Conditions
(from sponsor)		 Pulmonary Hypertension, Metal Poison
Related terms Heavy Metal Poisoning, Hypertension, Pulmonary
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov