Status:
COMPLETED
Cardiovagal Baroreflex Deficits Impair Neurovascular Coupling and Cognition in POTS
Lead Sponsor:
New York Medical College
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Postural Orthostatic Tachycardia Syndrome (POTS)
POTS
Eligibility:
FEMALE
15-30 years
Phase:
EARLY_PHASE1
Brief Summary
Postural tachycardia syndrome (POTS), is the chronic form of orthostatic intolerance associated with excessive upright tachycardia, and occurs predominantly in young females (\>85%). Among its most tr...
Detailed Description
Orthostatic intolerance is defined by debilitating upright symptoms that are relieved by sitting or lying. Symptoms include upright lightheadedness, fatigue, confusion, and decreased memory called 'Br...
Eligibility Criteria
Inclusion
- Inclusion Criteria for POTS patients:
- POTS patients referred for day to day orthostatic intolerance with greater than 3 symptoms for greater than 3 months and will have the diagnosis of symptomatic postural tachycardia made during a screening tilt table test :
- dizziness
- nausea and vomiting
- palpitations
- fatigue
- headache
- exercise intolerance
- blurred vision
- abnormal sweating heat.
- Healthy control subjects:
- normal physical examination, and normal electrocardiographic and echocardiographic evaluations.
- Only those free from heart disease, and from systemic illness will be eligible to participate.
- This excludes patients with illnesses and disease states known to be associated with endothelial cell dysfunction such as diabetes, renal disease, congestive heart failure, systemic hypertension, acute and chronic inflammatory diseases, neoplasm, immune mediated disease, trauma, morbid obesity and peripheral vascular disease.
- At the time of testing all patients and control subjects must refrain from vasoactive drugs for two weeks.
- Exclusion Criteria for both POTS and healthy controls:
- An active medical condition that may explain the diagnosis
- A previous medical condition with undocumented resolution that may explain the diagnosis
- any systemic or overt structural, arrhythmic or myopathic cardiovascular disease
- any illnesses known to produce autonomic dysfunction such as diabetes, heart disease, renal disease, systemic hypertension, acute and chronic inflammatory diseases, neoplastic disease, immune mediated disease, major trauma and burns, morbid obesity and peripheral vascular disease will also be excluded.
- Cigarette smokers will be excluded.
- Past or present major psychiatric disorder
- Substance abuse within 2 years before onset of symptoms.
Exclusion
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03261570
Start Date
July 1 2017
End Date
June 1 2022
Last Update
September 28 2022
Active Locations (1)
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1
New York Medical College/Bradhurst building
Hawthorne, New York, United States, 10532