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Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)

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Vanderbilt University

Status

Completed

Conditions

Postural Tachycardia Syndrome

Treatments

Drug: Cosyntropin administration

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01764711
R01HL102387 (U.S. NIH Grant/Contract)
121548

Details and patient eligibility

About

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)

Full 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.

Enrollment

13 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 2 patient groups

Low Salt Diet POTS
Experimental group
Description:
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.
Treatment:
Drug: Cosyntropin administration
Low Sodium Diet Controls
Experimental group
Description:
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.
Treatment:
Drug: Cosyntropin administration

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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