Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)
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|ClinicalTrials.gov Identifier: NCT01764711|
Recruitment Status : Active, not recruiting
First Posted : January 9, 2013
Last Update Posted : May 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Postural Tachycardia Syndrome||Drug: Cosyntropin administration||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome Participating in the Dietary Salt in Orthostatic Tachycardia Study.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
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
- Adrenal responsiveness to adrenocorticotropin hormone. (ACTH) [ Time Frame: 24 hours ]To assess the adrenal responsiveness to adrenocorticotropin hormone (ACTH), as measured by plasma aldosterone level, is contributing to the pathophysiology of Orthostatic Tachycardia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764711
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Alfredo J Gamboa, MD||Vanderbilt University Medical Center|