Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)

NCT01764711 | Completed Results

• 2 other identifiers: 121548R01HL102387
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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)

Conditions

Postural Tachycardia Syndrome

Keywords

POTS

Outcome Measures

Primary Outcomes (1)

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

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

  30 minutes after injection of ACTH

Study Arms (2)

Low Salt Diet POTS

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.

Drug: Cosyntropin administration

Low Sodium Diet Controls

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.

Drug: Cosyntropin administration

Interventions

Cosyntropin administration DRUG

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.

Also known as: Cortrosyn

Low Salt Diet POTS; Low Sodium Diet Controls

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Cosyntropin

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Adrenocorticotropic Hormone; Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Alfredo Gamboa
• Organization: Vanderbilt Universtiy

alfredo.gamboa@vumc.org

6158751003

Study Officials

• Alfredo J Gamboa, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor of Medicine

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: January 1, 2013
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 31, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Locations

US (1)