Overview

This trial is active, not recruiting.

Condition postural tachycardia syndrome
Treatment cosyntropin administration
Sponsor Vanderbilt University
Collaborator National Institutes of Health (NIH)
Start date January 2013
End date December 2017
Trial size 50 participants
Trial identifier NCT01764711, 120612, R01HL102387

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
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.
cosyntropin administration Cortrosyn
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.

Primary Outcomes

Measure
Adrenal responsiveness to adrenocorticotropin hormone. (ACTH)
time frame: 24 hours

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.