Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)
This trial is active, not recruiting.
|Condition||postural tachycardia syndrome|
|Collaborator||National Institutes of Health (NIH)|
|Start date||January 2013|
|End date||December 2017|
|Trial size||50 participants|
|Trial identifier||NCT01764711, 120612, R01HL102387|
This study is to determine different chemical levels in the blood during a low salt diet. This study will compare normal volunteers to those with Postural Tachycardia Syndrome (POTS)
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||single group assignment|
Adrenal responsiveness to adrenocorticotropin hormone. (ACTH)
time frame: 24 hours
Male or female participants from 18 years up to 50 years old.
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 - 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.
|Official title||Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome Participating in the Dietary Salt in Orthostatic Tachycardia Study.|
|Description||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.|
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