Evaluating the Prevalence of Acute Hepatic Porphyria in Postural Tachycardia Syndrome

StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Study completion pushed from Jun 30, 2026 to Dec 30, 2026
    • Eligibility criteria expanded, about 12 words
    • Publications: details revised at 5 of 5 entries
    • Study description expanded, about 2 words
  2. Study completion date: Dec 30, 2025 to Jun 30, 2026v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 2 to 1
    • Primary completion date changed from estimate of Jun 30, 2025 to Dec 30, 2024
    v6
  4. Primary completion date: Jun 30, 2024 to Jun 30, 2025
    • Enrollment target: 50 to 70
    • Study completion date: Jun 30, 2024 to Dec 30, 2025
    v5
  5. Primary completion date: Jan 18, 2024 to Jun 30, 2024
    • Study completion date: Jan 18, 2025 to Jun 30, 2024
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Primary completion date: Jan 18, 2023 to Jan 18, 2024v2
  1. Study First Submitted
  • 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.
Postural Tachycardia Syndrome (POTS) is the most common autonomic disorder and is estimated to affect 3,000,000 individuals in the United States, with 80-85% of patients being women. The condition is characterized by a rapid increase in heart rate (HR) that occurs on standing, and chronic symptoms of cerebral hypoperfusion leading to lightheadedness, dizziness, and blurred vision. The acute hepatic porphyrias(AHP)are among the diseases that present with autonomic cardiovascular(tachycardia)and neurovisceral symptoms (abdominal pain) among others; they present with acute exacerbations Given that there is available treatment for AHP that change the natural progression of the disease, study focuses to investigate the occurrence of AHP in POTS and determine the clinical and neuro-hormonal characteristic of the POTS subgroup that will likely benefit from AHP screening. This study has one visit that involves, answering some questionnaires, coming to the lab for blood work, genetic testing, and some autonomic function tests. About 50 people will take part in this study.
Trial Details
NCT Number NCT05344599
Lead Sponsor Vanderbilt University Medical Center
Conditions
(from sponsor)		 Postural Orthostatic Tachycardia Syndrome, Acute Hepatic Porphyria
Related terms Coproporphyria, Hereditary, Postural Orthostatic Tachycardia Syndrome
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov