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NCT05344599

Evaluating the Prevalence of Acute Hepatic Porphyria in Postural Tachycardia Syndrome

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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 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.

Official title: Estimating the Frequency and Neuro-Hormonal Characteristics of Acute Hepatic Porphyria in Postural Tachycardia Syndrome

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2022-01-19

Completion Date

2026-06-30

Last Updated

2026-01-23

Healthy Volunteers

Not specified

Interventions

DIAGNOSTIC_TEST

Autonomic Function Testing

Autonomic function test (orthostatic blood pressure and heart rate response to tilt, heart rate response to deep breathing, the Valsalva ratio, and beat-to-beat blood pressure measurements during phases II and IV of the Valsalva maneuver, tilt, and deep breathing). These combined tests provide a measurement of adrenergic, cardiovagal responses.

DIAGNOSTIC_TEST

Genetic Testing

Genetic testing: for Acute hepatic porphyria panel - with intent to use Saliva kit

DIAGNOSTIC_TEST

Urine Testing

Urine PBG, ALA and porphyrins in a spot urine sample with results normalized to urine creatinine

DIAGNOSTIC_TEST

Blood laboratory Testing

To determine the following laboratory analyses: CBC, CMP, Iron studies (Ferritin and iron studies)

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States