Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)

NCT ID: NCT01764711

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2020-12-31

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)

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.

Conditions

Postural Tachycardia Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cosyntropin administration

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Cosyntropin administration

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Cortrosyn

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Alfredo Gamboa

Research Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alfredo J Gamboa, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R01HL102387

Identifier Type: NIH

Identifier Source: secondary_id

View Link

121548

Identifier Type: -

Identifier Source: org_study_id