Clinical trial NCT01764711: Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)
Official title: Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome Aim 1b: ACTH Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Tachycardia Syndrome
Keywords: POTS
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-01-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Alldosterone Increase in Response to Adrenocorticotropin Hormone (ACTH).
timeFrame: 30 minutes after injection of ACTH
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alfredo J Gamboa, MD
role: PRINCIPAL_INVESTIGATOR
References: