Status:
ACTIVE_NOT_RECRUITING
Evaluating the Prevalence of Acute Hepatic Porphyria in Postural Tachycardia Syndrome
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Postural Orthostatic Tachycardia Syndrome
Acute Hepatic Porphyria
Eligibility:
All Genders
18-65 years
Brief Summary
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 ...
Detailed Description
Postural Tachycardia Syndrome (POTS) affects \~3 million young women in the United States.(1)These patients have a low quality of life because of chronic presyncopal symptoms, and orthostatic tachycar...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 18 - 65 years
- Individuals having an established diagnosis of POTS defined as the presence of presyncopal symptoms for more than 6 months and orthostatic tachycardia (\>30 bpm increase in HR within 10 min after assuming upright position)
- The present of one of the following criteria:
- 1 Family history of acute hepatic porphyria 3.2 Unexplained recurrent (more than one), prolonged (\>24 hours) episode of severe, diffuse (poorly localized) abdominal pain AND at least TWO of the following:
- Red to brownish urine.
- Blistering skin lesions on sun-exposed areas.
- Peripheral nervous system manifestations occurring around the time of abdominal pain (i.e., motor neuropathy (paresis), sensory neuropathy (numbness, tingling, limb pain).
- Central nervous system manifestations occurring around the time of abdominal pain (i.e. confusion, anxiety, seizures, hallucinations).
- Autonomic nervous system manifestations occurring around the time of abdominal pain (i.e. hyponatremia(Na\<lower limit of normal)), tachycardia, hypertension, nausea and vomiting, constipation).
- Exclusion Criteria
- Pregnant or breastfeeding women
- type 2 diabetes mellitus
- History of alcohol or drug abuse
- Inability to provide informed consent or comply with protocol
Exclusion
Key Trial Info
Start Date :
January 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05344599
Start Date
January 19 2022
End Date
December 30 2025
Last Update
January 17 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232