Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)
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ClinicalTrials.gov Identifier: NCT01764711 |
Recruitment Status :
Completed
First Posted : January 9, 2013
Results First Posted : March 31, 2022
Last Update Posted : March 31, 2022
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Condition or disease | Intervention/treatment | Phase |
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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) |
Actual Enrollment : | 13 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome Aim 1b: ACTH Stimulation |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | December 31, 2020 |
Actual Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
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Experimental: Low Salt Diet POTS
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.
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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 |
Experimental: Low Sodium Diet Controls
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 |
- Alldosterone Increase in Response to Adrenocorticotropin Hormone (ACTH). [ Time Frame: 30 minutes after injection of ACTH ]To assess the adrenal responsiveness to adrenocorticotropin hormone (ACTH), as measured by plasma aldosterone level, is contributing to the pathophysiology of Orthostatic Tachycardia.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects will be enrolled in the parent study "Dietary Salt in Postural Tachycardia Syndrome" during the "LOW SALT" phase
Postural Tachycardia Syndrome Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center Increase in heart rate ≥30 beats/min with position change from supine to standing (10 minutes) Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
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Control Subjects
- Healthy, non-obese, non-smokers without orthostatic tachycardia
- Selected to match profiles of POTS patients (gender, age)
- Not using vasoactive medication
- Age between 18-50 years
- Male and female subjects are eligible.
- Able and willing to provide informed consent
Exclusion Criteria:
- Overt cause for postural tachycardia (such as acute dehydration)
- Inability to give, or withdrawal of, informed consent
- pregnant
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.

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 |
Documents provided by Alfredo Gamboa, Vanderbilt University:
Responsible Party: | Alfredo Gamboa, Research Associate Professor of Medicine, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT01764711 |
Other Study ID Numbers: |
121548 R01HL102387 ( U.S. NIH Grant/Contract ) |
First Posted: | January 9, 2013 Key Record Dates |
Results First Posted: | March 31, 2022 |
Last Update Posted: | March 31, 2022 |
Last Verified: | March 2022 |
POTS |
Postural Orthostatic Tachycardia Syndrome Tachycardia Syndrome Disease Pathologic Processes Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Cardiac Conduction System Disease |
Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Cosyntropin Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |