Status:
COMPLETED
Gastrointestinal Symptoms in Postural Orthostatic Tachycardia Syndrome
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Postural Tachycardia Syndrome
Eligibility:
FEMALE
18-60 years
Brief Summary
Patients with POTS experience significant gastrointestinal symptoms. Current evidence suggesting that abnormal post-ganglionic sympathetic function could play a role in the pathophysiology of these GI...
Detailed Description
Postural Tachycardia Syndrome (POTS) is a disabling condition that mostly affects young women in their reproductive age. It is characterized by chronic (\>6 months) orthostatic intolerance symptoms (p...
Eligibility Criteria
Inclusion
- 18-60 years old
- Postural Tachycardia Syndrome: Heart rate increase \>30 bpm from supine within 10 min of standing, in the absence of orthostatic hypotension (\>20/10 mmHg fall in blood pressure), with chronic symptoms (\> 6 months), and in the absence of other acute cause of orthostatic tachycardia.
- Able and willing to provide informed consent
- Female premenopausal subjects must utilize adequate birth control and willingness to undergo serum beta-hCG (human chorionic gonadotropin) testing
Exclusion
- Use of acetaminophen or acetaminophen-related drugs (over-the-counter) in the 24 hours prior to the study.
- Hypertension (\>150 mmHg systolic and \>100 mmHg diastolic) based on history or findings on screening.
- Orthostatic hypotension (consistent decrease in BP \>20/10 mmHg with 10 min stand)
- Pregnancy
- History of type 1 or type 2 diabetes mellitus
- Cardiovascular disease, such as myocardial infarction within 6 months, angina pectoris, significant arrhythmia (sinus tachycardia is not excluded), deep vein thrombosis, pulmonary embolism
- History of serious neurologic disease
- Impaired hepatic function (aspartate amino transaminase and/or alanine amino transaminase \>1.5 x upper limit of normal range)
- Impaired renal function (serum creatinine \>1.5 mg/dL)
- Hematocrit \<28%
- Any underlying or acute disease requiring regular medication that could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
- Inability to comply with the protocol
- Healthy control subjects
- Defined as subjects without any significant past medical history, non-smokers, and on no chronic medications at the time of the study. Healthy control subjects will be age- and BMI-matched to the POTS patients.
- Positive control
- Patients with complete autonomic neuropathy (pure autonomic failure) will be enrolled as positive control. This condition is defined as complete autonomic failure based on AFT (autonomic function test) and norepinephrine plasma levels less than 100 pg/ml.
Key Trial Info
Start Date :
June 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03263819
Start Date
June 20 2017
End Date
December 31 2020
Last Update
July 8 2024
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232