Postural Tachycardia Syndrome Clinical Trial
Official title:
Assessment of Vascular Endothelial Function in Postural Tachycardia Syndrome (POTS)
Verified date | January 2017 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to see if people with Postural Tachycardia Syndrome (POTS) have
different levels of certain chemicals in their blood than people who don't have POTS. This
study will test whether the blood vessels of people with POTS will react differently to
certain tests than people without POTS.
The hypothesis of the study is:
Patients with POTS will have vascular endothelial dysfunction compared with control
subjects.
Status | Completed |
Enrollment | 26 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: ALL: - Ages between 18-60 years old - Male and female subjects are eligible - Able and willing to give informed consent Additional criteria for POTS: - Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic - Dysfunction Center (1. increase in heart rate >/= 30 beats/minute with position change from supine to standing for 10 minutes and/or 2. Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence. Additional criteria for Control subjects: - Healthy, non-obese, non-smokers without orthostatic tachycardia - Selected to match profiles of POTS patients (gender, age) - Not using vasoactive medications Exclusion Criteria: - Overt cause for postural tachycardia (such as acute dehydration) - Inability to give, or withdraw informed consent - Pregnancy - Other factors in the investigator's opinion would prevent the subject from completing the study |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RH-PAT index | The primary analysis of RH-PAT will involve a non-parametric, Mann Whitney U test of RH-PAT between POTS patients and Control subjects. | The study will be complete in approximately 2 hours. There is no follow-up to this study. |
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