Status:
ACTIVE_NOT_RECRUITING
Autonomic Determinants of POTS - Pilot1
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Postural Tachycardia Syndrome
Eligibility:
FEMALE
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
Postural tachycardia syndrome (POTS) is a relatively common condition affecting mostly otherwise healthy young women. It is the cause of significant disability and an impairment in quality of life. Th...
Detailed Description
Postural tachycardia syndrome (POTS) is a relatively common condition affecting mostly otherwise healthy young women. It is the cause of significant disability and an impairment in quality of life of ...
Eligibility Criteria
Inclusion
- female/male subjects, age 18-55 years,
- criteria for postural tachycardia syndrome (POTS):
- a heart rate increase of ≥30 beats/min within 10 minutes of upright posture;
- lack of orthostatic hypotension (blood pressure fall ≥ 20/10 mmHg within 10 minutes of standing); and
- chronic symptoms during upright posture over at least 6 months, in the absence of any other acute cause.
- in the follicular phase of the menstrual cycle (day 5-13 of a 28-day cycle)
- POTS with primary central sympathetic activation (psPOTS) as defined as having resting muscle sympathetic nerve activity (MSNA) greater than or equal to 25 bursts/min
- able and willing to provide informed consent.
Exclusion
- pregnancy,
- smoker,
- BMI\>30 kg/m2,
- deconditioned status (if available VO2max\<80% of predicted)
- unable to withdraw from medications known to affect autonomic function, blood pressure or blood volume
- systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
- Arteriosclerotic disease of carotid artery. History of neck surgery.
- conditions associated with inflammatory processes, such as coronary artery disease, hypertension, smoking, hypercholesterolemia (or on statin therapy), rheumatoid arthritis, diabetes
- treatment with oral corticosteroids, current infections (e.g., urinary tract infection), or use of non-steroidal anti-inflammatory drugs
- other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing.
Key Trial Info
Start Date :
August 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04050410
Start Date
August 27 2019
End Date
December 31 2025
Last Update
January 31 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232