A Study of Postural Tachycardia Syndrome
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-001436
Sponsor Protocol Number: 12-001436
About this study
The purpose of this research study is to better understand what causes POTS. We believe that a number of different causes of POTS exist and that detailed testing can demonstrate the different causes. Knowing what causes POTS in a particular patient will be helpful in choosing the right treatment strategy for that particular patient in the future.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
POTS:
- Males or females age 18-50 years.
- Orthostatic HR increment of ≥30bpm to an absolute orthostatic HR ≥120bpm within 10 min of head-up tilt.
- Frequent orthostatic symptoms (lightheadedness, faintness), that resolve promptly with recumbency
Control Subjects:
- Males or females age 18-50 years, age and gender matched to patients
- Normal Autonomic Reflex Screen, normal Autonomic Symptom Profile
Subjects Undergoing Skin Biopsy and Autonomic Reflex Screen Only
- Males or females age 18-80 years
Exclusion Criteria
POTS and Controls
- Orthostatic hypotension (decrease of systolic BP≥30mmHg and/or diastolic BP≥15mmHg within 3min of tilt)
- Pregnant/lactating females – a pregnancy test will be required for women of childbearing potential.
- The presence of failure of other organ systems or systemic illness that can affect autonomic function.
- Concomitant therapy with anticholinergic, alpha-/beta-adrenergic antagonists or other medication which could interfere with autonomic testing. Potentially interfering medication will be held for five half-lives.
Subjects Only Undergoing Skin Biopsy and Autonomic Reflex Screen Only
- Pregnant/lactating females – a pregnancy test will be required for women of childbearing potential.
- The presence of failure of other organ systems or systemic illness that can affect autonomic function.
- Concomitant therapy with anticholinergic, alpha-/beta-adrenergic antagonists or other medication which could interfere with autonomic testing. Potentially interfering medication will be held for five half-lives.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Wolfgang Singer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available