Postural Tachycardia SyndromeNCT01764711
Adrenocorticotropic Hormone Stimulation in Postural Orthostatic Tachycardia Syndrome (POTS)
A study testing Cosyntropin administration in people with Postural Tachycardia Syndrome, run by Vanderbilt University at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Tachycardia Syndrome
- What is being tested?
- Cosyntropin administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Age between 18-50 years
- Male and female subjects are eligible.
- Able and willing to provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome Aim 1b: ACTH Stimulation
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)
Read the 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
- Being tested
- Cosyntropin administration
- Keywords
- POTS
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosyntropin administrationDrug
Also called Cortrosyn
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Cosyntropin administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after injection of ACTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJan 2013
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postural Tachycardia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alfredo Gamboa, Vanderbilt University
- Investigators
- Alfredo J Gamboa, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764711
- Sponsor's protocol ID
- 121548
- Other IDs
- R01HL102387
- Status last verified
- Mar 2022
- First submitted
- 7 Jan 2013
- Last updated
- 31 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome Aim 1b: ACTH Stimulation
- ClinicalTrials.gov ID
- NCT01764711
- Acronym / sponsor ID
- 121548
- Conditions
- Postural Tachycardia Syndrome
- Keywords
- POTS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2013
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Posted 31 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Salt Diet POTS | Experimental | Drug: Cosyntropin administrationEach 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. |
| Low Sodium Diet Controls | Experimental | Drug: Cosyntropin administrationEach 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
- Age between 18-50 years
- Male and female subjects are eligible.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosyntropin administrationAlso: CortrosynAfter 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. | Drug | Low Salt Diet POTS, Low Sodium Diet Controls |
Primary outcome
Alldosterone Increase in Response to Adrenocorticotropin Hormone (ACTH).
Time frame: 30 minutes after injection of ACTH
To assess the adrenal responsiveness to adrenocorticotropin hormone (ACTH), as measured by plasma aldosterone level, is contributing to the pathophysiology of Orthostatic Tachycardia.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Postural Tachycardia Syndrome
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome
Postural Tachycardia Syndrome
Enrolling by invitationObservational study
Presentation of Young Adults With and Without Joint Hypermobility
Hypermobile Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS)
Active, not recruitingObservational study
POTS NET mRNA Functional Correlation With NET Activity
Postural Tachycardia Syndrome
Active, not recruiting
Acute Salt Handling in Orthostatic Intolerance
Postural Tachycardia Syndrome, Orthostatic Tachycardia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo J Gamboa, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosyntropin administration in people with Postural Tachycardia Syndrome, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alldosterone Increase in Response to Adrenocorticotropin Hormone (ACTH). (time frame: 30 minutes after injection of ACTH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.