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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)

NCTNCT01764711 (opens ClinicalTrials.gov in a new tab)Other id121548Other idR01HL102387
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
13 participants (actual)
Sponsor
Vanderbilt University · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Jan 2013
Primary completion
31 Dec 2020
Completion
31 Dec 2020
First posted
9 Jan 2013 (estimated)
Last update posted
31 Mar 2022
Conditions
Postural Tachycardia Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201620182020
  1. N/A

    Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)

    NCT01764711

    Jan 2013 to 31 Dec 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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)

Interventions

  • Cosyntropin administrationDrug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Alldosterone Increase in Response to Adrenocorticotropin Hormone (ACTH).

    Time frame · 30 minutes after injection of ACTH

    Registry description

    To assess the adrenal responsiveness to adrenocorticotropin hormone (ACTH), as measured by plasma aldosterone level, is contributing to the pathophysiology of Orthostatic Tachycardia.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 30 minutes after injection of ACTH

Alldosterone Increase in Response to Adrenocorticotropin Hormone (ACTH).

GroupValue (nanograms/dL)Spread
Low Salt Diet POTS52.515.7
Low Salt Diet Controls57.926.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Low Salt Diet POTSEach 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: 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.0 / 80 / 80 / 8
Low Salt Diet ControlsEach 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: 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.0 / 50 / 50 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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