Postural Tachycardia SyndromeNCT00748228
Dopamine in Orthostatic Tolerance
A study testing dietary sodium in people with Postural Tachycardia Syndrome, run by Vanderbilt University at 1 site in United States.
Trial summary
One goal of this study is to determine whether people with different amounts of dopamine-beta-hydroxylase (DBH) have different responses to events that affect blood pressure and heart rate. We will also study whether increasing dietary salt improves symptoms during upright posture. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Tachycardia Syndrome
- What is being tested?
- dietary sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Upright plasma norepinephrine > 600 pg/ml, or
- An increase in heart rate of > 30 beats per minute upon standing, and
- Withdrawal of all medications for at least 3 days, and
- No associated medical illness, and
- Age 18 - 60 years old.
Who cannot join
- Older than 60 years of age
- Routinely taking medications affecting the autonomic nervous system
- Any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic) other than POTS
- Anemia (Hct < 30)
- Women of childbearing age who are pregnant or nursing
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
One goal of this study is to determine whether people with different amounts of dopamine-beta-hydroxylase (DBH) have different responses to events that affect blood pressure and heart rate. We will also study whether increasing dietary salt improves symptoms during upright posture. Finally, we will examine whether the dietary sodium level influences serum DBH activity and whether DBH level influences the response to sodium. DBH levels and the function of the sympathetic or involuntary nervous system will be assessed in normal volunteers and in patients with postural tachycardia syndrome (POTS).
- Conditions
- Postural Tachycardia Syndrome
- Being tested
- dietary sodium
- 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.
dietary sodiumDietary supplement
10 mEq/day
dietary sodiumDietary supplement
300 mEq/day
dietary sodiumDietary supplement
150 mEq/day dietary sodium
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 10 mEq/day dietary sodium Receives: Dietary Supplement: dietary sodium |
| B | Experimental | 150 mEq/day dietary sodium Receives: Dietary Supplement: dietary sodium |
| C | Experimental | 300 mEq/day dietary sodium Receives: Dietary Supplement: dietary sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma dopamine-beta-hydroxylase
Measured: at enrollment and after tests
plasma dopamine
Measured: after tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startNov 2004
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: This study is being replaced by another protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily M. Garland, Vanderbilt University
- Investigators
- Emily M Garland, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748228
- Sponsor's protocol ID
- 040769
- Other IDs
- HL071784
- Status last verified
- Jun 2015
- First submitted
- 5 Sep 2008
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine in Orthostatic Tolerance
- ClinicalTrials.gov ID
- NCT00748228
- Acronym / sponsor ID
- 040769
- Conditions
- Postural Tachycardia Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study is being replaced by another protocol.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One goal of this study is to determine whether people with different amounts of dopamine-beta-hydroxylase (DBH) have different responses to events that affect blood pressure and heart rate. We will also study whether increasing dietary salt improves symptoms during upright posture. Finally, we will examine whether the dietary sodium level influences serum DBH activity and whether DBH level influences the response to sodium. DBH levels and the function of the sympathetic or involuntary nervous system will be assessed in normal volunteers and in patients with postural tachycardia syndrome (POTS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: dietary sodium10 mEq/day dietary sodium |
| B | Experimental | Dietary Supplement: dietary sodium150 mEq/day dietary sodium |
| C | Experimental | Dietary Supplement: dietary sodium300 mEq/day dietary sodium |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Upright plasma norepinephrine > 600 pg/ml, or
- An increase in heart rate of > 30 beats per minute upon standing, and
- Withdrawal of all medications for at least 3 days, and
- No associated medical illness, and
- Age 18 - 60 years old.
Key exclusion criteria (6 listed)
- Older than 60 years of age
- Routinely taking medications affecting the autonomic nervous system
- Any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic) other than POTS
- Anemia (Hct < 30)
- Women of childbearing age who are pregnant or nursing
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 |
|---|---|---|
| dietary sodium10 mEq/day | Dietary supplement | A |
| dietary sodium300 mEq/day | Dietary supplement | C |
| dietary sodium150 mEq/day dietary sodium | Dietary supplement | B |
Primary outcome
plasma dopamine-beta-hydroxylase
Time frame: at enrollment and after tests
plasma dopamine
Time frame: after tests
Results and safety
The study was stopped early (reason given: This study is being replaced by another protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
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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.
Emily M Garland, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary sodium 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Jun 2015. 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?
The study was stopped early (reason given: This study is being replaced by another protocol.). Results are not available in the source record.
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?
plasma dopamine-beta-hydroxylase (time frame: at enrollment and after tests). The study lists 2 primary outcomes in all. 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 15 Jun 2015.