Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01764711
First received: January 7, 2013
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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)


Condition Intervention
Postural Tachycardia Syndrome
Drug: Cosyntropin administration

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome Participating in the Dietary Salt in Orthostatic Tachycardia Study.

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Adrenal responsiveness to adrenocorticotropin hormone. (ACTH) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    To assess the adrenal responsiveness to adrenocorticotropin hormone (ACTH), as measured by plasma aldosterone level, is contributing to the pathophysiology of Orthostatic Tachycardia.


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Salt Diet
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
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.
Other Name: Cortrosyn

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764711

Contacts
Contact: Satish Raj, MD, MSCI 615-322-2931 adcresearch@vanderbilt.edu
Contact: Victor Nwazue, MD 615-322-2931 adcresearch@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Satish Raj, MD, MSCI    615-322-2931    adcresearch@vanderbilt.edu   
Contact: Victor Nwazue, MD    615-322-2931    adcresearch@vanderbilt.edu   
Principal Investigator: Satish Raj, MD, MSCI         
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Satish R. Raj, Assistant Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01764711     History of Changes
Other Study ID Numbers: 120612
Study First Received: January 7, 2013
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
POTS

Additional relevant MeSH terms:
Orthostatic Intolerance
Syndrome
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Adrenocorticotropic Hormone
Cosyntropin
Beta-Endorphin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014