Postural Orthostatic Tachycardia Syndrome Clinical Trial
Official title:
Estimating the Frequency and Neuro-Hormonal Characteristics of Acute Hepatic Porphyria in Postural Tachycardia Syndrome
NCT number | NCT05344599 |
Other study ID # | 210724 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 19, 2022 |
Est. completion date | June 30, 2024 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria 1. Age 18 - 65 years 2. 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) 3. The present of one of the following criteria: 3.1 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 1. Pregnant or breastfeeding women 2. type 2 diabetes mellitus 3. History of alcohol or drug abuse 4. Inability to provide informed consent or comply with protocol |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Garland EM, Raj SR, Black BK, Harris PA, Robertson D. The hemodynamic and neurohumoral phenotype of postural tachycardia syndrome. Neurology. 2007 Aug 21;69(8):790-8. doi: 10.1212/01.wnl.0000267663.05398.40. — View Citation
Loavenbruck A, Iturrino J, Singer W, Sletten DM, Low PA, Zinsmeister AR, Bharucha AE. Disturbances of gastrointestinal transit and autonomic functions in postural orthostatic tachycardia syndrome. Neurogastroenterol Motil. 2015 Jan;27(1):92-8. doi: 10.111 — View Citation
Raj SR. The Postural Tachycardia Syndrome (POTS): pathophysiology, diagnosis & management. Indian Pacing Electrophysiol J. 2006 Apr 1;6(2):84-99. — View Citation
Robertson D. The epidemic of orthostatic tachycardia and orthostatic intolerance. Am J Med Sci. 1999 Feb;317(2):75-7. doi: 10.1097/00000441-199902000-00001. No abstract available. — View Citation
Schondorf R, Low PA. Idiopathic postural orthostatic tachycardia syndrome: an attenuated form of acute pandysautonomia? Neurology. 1993 Jan;43(1):132-7. doi: 10.1212/wnl.43.1_part_1.132. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AHP Case ascertainment in POTS patients | Evaluating the Prevalence of Acute Hepatic Porphyria in Postural Tachycardia Syndrome | During the intervention |
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