Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome Participating in the Dietary Salt in Orthostatic Tachycardia Study.|
- Adrenal responsiveness to adrenocorticotropin hormone. (ACTH) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]To assess the adrenal responsiveness to adrenocorticotropin hormone (ACTH), as measured by plasma aldosterone level, is contributing to the pathophysiology of Orthostatic Tachycardia.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Low Salt Diet
Each participant will be asked to sit in a chair for 30 minutes prior to a blood draw. Then a small dose of cosyntropin is administered intravenous. Blood samples will be drawn again at 30 minutes and 60 minutes after the drug has been given.
Drug: Cosyntropin administration
After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
Other Name: Cortrosyn
Patients with postural tachycardia syndrome had a subnormal increment in aldosterone with upright posture, which might reflect a blunted adrenal response to stimulation upon assuming upright posture. In this AIM, we propose to assess the adrenal response to aldosterone stimulation with intravenous adrenocorticotropin hormone.
For this protocol, subjects enrolled in the parent study will be approached about this sub-study. Subjects will be assured that they are not required to participate in this study even if they choose to participate in the parent study.
There will be no randomization for this specific sub-study. The order of diets (low sodium vs. high sodium) will be performed as a part of the parent study, and not as a part of this sub-study. This sub-study will only be performed in the LOW dietary salt phase.
All subjects will be previously screened and evaluated as a part of the parent study. No further screening will be performed exclusively for this study. Women of childbearing potential will have had a serum pregnancy test as a part of the parent study. Pregnant women will not be allowed to participate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764711
|Contact: Satish Raj, MD, MSCIemail@example.com|
|Contact: Victor Nwazue, MDfirstname.lastname@example.org|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Contact: Satish Raj, MD, MSCI 615-322-2931 email@example.com|
|Contact: Victor Nwazue, MD 615-322-2931 firstname.lastname@example.org|
|Principal Investigator: Satish Raj, MD, MSCI|